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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04639258
Registration number
NCT04639258
Ethics application status
Date submitted
5/11/2020
Date registered
20/11/2020
Date last updated
10/01/2024
Titles & IDs
Public title
Medtronic Evolut™ EXPAND TAVR I Feasibility Study
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Scientific title
Medtronic Evolut™ EXPAND TAVR I Feasibility Study
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Secondary ID [1]
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D00266108
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Aortic Valve Stenosis
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Medtronic Evolut™ PRO+ System
Experimental: Medtronic Evolut™ PRO+ System - All study subjects will be treated with the Medtronic Evolut™ PRO+ TAVR System.
Treatment: Devices: Medtronic Evolut™ PRO+ System
TAVR treatment with Medtronic Evolut™ PRO+ System
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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All-cause and Cardiovascular Mortality
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Assessment method [1]
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Rate of all-cause and cardiovascular mortality
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Timepoint [1]
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30 days
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Primary outcome [2]
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All-cause and Cardiovascular Mortality
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Assessment method [2]
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Rate of all-cause and cardiovascular mortality
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Timepoint [2]
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6 months
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Primary outcome [3]
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All Stroke (Disabling and Non-disabling)
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Assessment method [3]
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Rate of disabling and non-disabling stroke
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Timepoint [3]
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30 days
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Primary outcome [4]
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All Stroke (Disabling and Non-disabling)
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Assessment method [4]
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Rate of disabling and non-disabling stroke
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Timepoint [4]
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6 months
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Primary outcome [5]
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Myocardial Infarction (Periprocedural and Spontaneous)
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Assessment method [5]
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Rate of periprocedural and spontaneous myocardial infarction
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Timepoint [5]
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30 days
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Primary outcome [6]
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Myocardial Infarction (Periprocedural and Spontaneous)
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Assessment method [6]
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Rate of periprocedural and spontaneous myocardial infarction
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Timepoint [6]
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6 months
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Primary outcome [7]
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Acute Kidney Injury
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Assessment method [7]
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Rate of acute kidney injury
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Timepoint [7]
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30 days
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Primary outcome [8]
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Acute Kidney Injury
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Assessment method [8]
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Rate of acute kidney injury
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Timepoint [8]
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6 months
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Primary outcome [9]
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Major Vascular Complications
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Assessment method [9]
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Rate of major vascular complications
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Timepoint [9]
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30 days
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Primary outcome [10]
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Major Vascular Complications
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Assessment method [10]
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Rate of major vascular complications
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Timepoint [10]
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6 months
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Primary outcome [11]
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Life-threatening Bleed
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Assessment method [11]
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Rate of life-threatening (or disabling) bleed
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Timepoint [11]
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30 days
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Primary outcome [12]
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Life-threatening Bleed
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Assessment method [12]
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Rate of life-threatening (or disabling) bleed
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Timepoint [12]
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6 months
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Primary outcome [13]
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New Permanent Pacemaker Implantation (PPI)
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Assessment method [13]
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Rate of new permanent pacemaker implantation (excludes patients with pre-existing pacemakers at baseline)
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Timepoint [13]
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30 days
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Primary outcome [14]
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New Permanent Pacemaker Implantation (PPI)
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Assessment method [14]
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Rate of new permanent pacemaker implantation (excludes patients with pre-existing pacemakers at baseline)
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Timepoint [14]
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6 months
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Primary outcome [15]
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New Intraventricular Conduction Delays
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Assessment method [15]
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Rate of new intraventricular conduction delays (excludes patients with intraventricular conduction delays at baseline)
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Timepoint [15]
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30 days
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Primary outcome [16]
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New Intraventricular Conduction Delays
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Assessment method [16]
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Rate of new intraventricular conduction delays (excludes patients with intraventricular conduction delays at baseline)
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Timepoint [16]
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6 months
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Primary outcome [17]
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New-onset Atrial Fibrillation
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Assessment method [17]
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Rate of new-onset atrial fibrillation (excludes patients with atrial fibrillation at baseline)
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Timepoint [17]
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30 days
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Primary outcome [18]
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New-onset Atrial Fibrillation
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Assessment method [18]
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Rate of new-onset atrial fibrillation (excludes patients with atrial fibrillation at baseline)
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Timepoint [18]
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6 months
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Primary outcome [19]
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Valve-related Dysfunction Requiring Repeat Procedure
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Assessment method [19]
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Rate of valve-related dysfunction requiring repeat procedure
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Timepoint [19]
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30 days
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Primary outcome [20]
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Valve-related Dysfunction Requiring Repeat Procedure
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Assessment method [20]
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Rate of valve-related dysfunction requiring repeat procedure
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Timepoint [20]
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6 months
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Primary outcome [21]
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Device Success (VARC-2)
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Assessment method [21]
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The VARC-2 definition of device success is absence of procedural mortality, correct positioning of a single prosthetic heart valve into the proper anatomical location, intended performance of the prosthetic heart valve, defined as the absence of patient-prosthesis-mismatch and mean aortic valve gradient less than 20 mmHg (or peak velocity <3 m/sec), and absence of moderate or severe prosthetic valve regurgitation
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Timepoint [21]
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Discharge (12 hours to 7 days post-procedure)
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Primary outcome [22]
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Cardiovascular and Heart Failure Hospitalizations
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Assessment method [22]
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Rate of cardiovascular and heart failure hospitalizations
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Timepoint [22]
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30 days
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Primary outcome [23]
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Cardiovascular and Heart Failure Hospitalizations
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Assessment method [23]
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Rate of cardiovascular and heart failure hospitalizations
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Timepoint [23]
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6 months
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Primary outcome [24]
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Heart Failure Events
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Assessment method [24]
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Rate of heart failure events
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Timepoint [24]
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30 days
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Primary outcome [25]
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Heart Failure Events
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Assessment method [25]
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Rate of heart failure events
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Timepoint [25]
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6 months
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Primary outcome [26]
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Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography
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Assessment method [26]
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Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient
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Timepoint [26]
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Discharge (12 hours to 7 days post-procedure)
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Primary outcome [27]
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Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography
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Assessment method [27]
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Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient
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Timepoint [27]
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30 days
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Primary outcome [28]
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Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography
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Assessment method [28]
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Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient
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Timepoint [28]
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6 months
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Primary outcome [29]
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Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography
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Assessment method [29]
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Change in hemodynamic performance metrics by Doppler echocardiography measured by effective orifice area.
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Timepoint [29]
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Discharge (12 hours to 7 days post-procedure)
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Primary outcome [30]
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Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography
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Assessment method [30]
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Change in hemodynamic performance metrics by Doppler echocardiography measured by effective orifice area.
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Timepoint [30]
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30 days
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Primary outcome [31]
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Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography
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Assessment method [31]
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Change in hemodynamic performance metrics by Doppler echocardiography measured by effective orifice area.
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Timepoint [31]
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6 months
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Primary outcome [32]
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Hemodynamic Performance Metrics (Degree of Total, Para, and Transvalvular Prosthetic Regurgitation) by Doppler Echocardiography
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Assessment method [32]
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Reporting of prosthetic valve hemodynamic performance by degree of total, para, and transvalvular regurgitation by Doppler echocardiography
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Timepoint [32]
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Discharge (12 hours to 7 days post-procedure)
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Primary outcome [33]
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Hemodynamic Performance Metrics (Degree of Total, Para, and Transvalvular Prosthetic Regurgitation) by Doppler Echocardiography
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Assessment method [33]
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Reporting of prosthetic valve hemodynamic performance by degree of total, para, and transvalvular regurgitation by Doppler echocardiography
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Timepoint [33]
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30 days
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Primary outcome [34]
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Hemodynamic Performance Metrics (Degree of Total, Para, and Transvalvular Prosthetic Regurgitation) by Doppler Echocardiography
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Assessment method [34]
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Reporting of prosthetic valve hemodynamic performance by degree of total, para, and transvalvular regurgitation by Doppler echocardiography
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Timepoint [34]
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6 months
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Primary outcome [35]
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Hemodynamic Performance Metrics (Incidence of Moderate and Severe Patient-prosthesis Mismatch) by Doppler Echocardiography
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Assessment method [35]
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Reporting of prosthetic valve hemodynamic performance by incidence of moderate and severe patient-prosthesis mismatch by Doppler echocardiography
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Timepoint [35]
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Discharge (12 hours to 7 days post-procedure)
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Primary outcome [36]
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Hemodynamic Performance Metrics (Incidence of Moderate and Severe Patient-prosthesis Mismatch) by Doppler Echocardiography
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Assessment method [36]
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Reporting of prosthetic valve hemodynamic performance by incidence of moderate and severe patient-prosthesis mismatch by Doppler echocardiography
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Timepoint [36]
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30 days
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Primary outcome [37]
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Hemodynamic Performance Metrics (Incidence of Moderate and Severe Patient-prosthesis Mismatch) by Doppler Echocardiography
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Assessment method [37]
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Reporting of prosthetic valve hemodynamic performance by incidence of moderate and severe patient-prosthesis mismatch by Doppler echocardiography
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Timepoint [37]
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6 months
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Primary outcome [38]
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Change From Baseline in New York Heart Association (NYHA) Functional Classification
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Assessment method [38]
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Reporting of NYHA classification change from baseline to 30 days and 6 months
NYHA Classification criteria:
Class I: Subjects with cardiac disease but without resulting limitations of physical activity.
Class I: Subjects with cardiac disease resulting in slight limitation of physical activity.
Class III: Subjects with cardiac disease resulting in marked limitation of physical activity.
Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.
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Timepoint [38]
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30 days and 6 months
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Primary outcome [39]
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Change From Baseline in Six-minute Walk Test (6MWT)
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Assessment method [39]
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Reporting change from baseline in distance walked during 6MWT
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Timepoint [39]
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6 months
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Primary outcome [40]
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Change From Baseline in Health-related Quality of Life (QoL) as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)
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Assessment method [40]
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KCCQ quantifies physical function, symptoms, social function, self-efficiency, knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
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Timepoint [40]
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30 days and 6 months
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Primary outcome [41]
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Change From Baseline in Left Ventricular Ejection Fraction (LVEF)
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Assessment method [41]
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Reporting of change in left ventricular ejection fraction (LVEF) from baseline by echocardiography
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Timepoint [41]
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6 months
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Primary outcome [42]
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Change From Baseline in Global Longitudinal Strain (GLS)
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Assessment method [42]
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Reporting of change in GLS from baseline by echocardiography
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Timepoint [42]
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6 months
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Primary outcome [43]
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Change From Baseline in Left Ventricular Filling Pressure (E:e')
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Assessment method [43]
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Reporting of change in left ventricular filling pressure (E:e') from baseline by echocardiography
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Timepoint [43]
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6 months
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Primary outcome [44]
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Change From Baseline in Stroke Volume Index (SVI)
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Assessment method [44]
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Reporting of change in stroke volume index (SVI) from baseline by echocardiography
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Timepoint [44]
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6 months
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Primary outcome [45]
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Change From Baseline in NT-pro B-type Natriuretic Peptide (NT-proBNP)
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Assessment method [45]
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Reporting of change in NT-pro B-type natriuretic peptide (NT-proBNP) from baseline
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Timepoint [45]
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6 months
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Eligibility
Key inclusion criteria
Key
- Severe aortic stenosis, defined as: Aortic valve area = 1.0 cm^2, or aortic valve area
index = 0.6 cm^2/m^2, and mean gradient = 40 mmHg or Vmax = 4.0 m/sec
- Subject denies symptoms attributable to aortic stenosis, including but not limited to:
- Dyspnea on rest or exertion
- Angina
- Syncope in the absence of another identifiable cause
- Fatigue
- Left Ventricular Ejection Fraction (LVEF) >50%
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Minimum age
65
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Age <65 years
- Class I indication for cardiac surgery
- Bicuspid, unicuspid, or quadricuspid aortic valve
- In need of and suitable for coronary revascularization
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/05/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
7/06/2022
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Sample size
Target
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Accrual to date
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Final
11
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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The Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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- Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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New York
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Country [3]
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0
United States of America
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State/province [3]
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Pennsylvania
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Country [4]
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0
United States of America
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State/province [4]
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Wisconsin
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Country [5]
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Canada
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State/province [5]
0
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Quebec
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Country [6]
0
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Israel
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State/province [6]
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Petah Tikva
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Country [7]
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New Zealand
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State/province [7]
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Hamilton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Medtronic Cardiovascular
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of the study is to obtain safety and effectiveness data of the Medtronic Evolut™
PRO+ TAVR System for the treatment of severe, asymptomatic aortic stenosis.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04639258
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Paul Sorajja, MD
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Address
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Allina Health System
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04639258
Download to PDF