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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/NCT02031302
Registration number
NCT02031302
Ethics application status
Date submitted
6/01/2014
Date registered
9/01/2014
Date last updated
19/11/2021
Titles & IDs
Public title
RESPOND Post Market Study
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Scientific title
RESPOND: Re-positionable Lotus Valve System - Post Market Evaluation of Real World Clinical Outcomes
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Secondary ID [1]
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TP6461
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Universal Trial Number (UTN)
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Trial acronym
RESPOND
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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
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Devices - Lotus Valve System
Lotus Valve - All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus Valve.
Lotus with Depth Guard - All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus with Depth Guard.
Treatment: Devices: Lotus Valve System
The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or index of <0.6 cm2/m2) who are at high risk for standard surgical valve replacement.
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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 Mortality
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Assessment method [1]
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The primary endpoint is all-cause mortality at 30 days after the implant procedure. The primary safety endpoint will be evaluated on an intention-to-treat (ITT) basis (all subjects enrolled, whether or not a Lotus Valve is implanted). All-cause mortality at 30 days after the implant procedure will be compared to a pre-specified performance goal.
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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 Mortality
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Assessment method [2]
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The primary endpoint is all-cause mortality at 1 year after the implant procedure. The primary safety endpoint will be evaluated on an intention-to-treat (ITT) basis (all subjects enrolled, whether or not a Lotus Valve is implanted).
A total of 116 subjects died through 1 year (365 days) post procedure (as treated population). 4 additional patients died but were not treated with the study valve system (ITT population).
The Lotus Valve cohort is an ongoing study in it's 4 year follow up. The Lotus with Depth Guard cohort ended after 30 day follow up, therefore we have no data at 1 year.
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Timepoint [2]
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1 Year
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Secondary outcome [1]
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Percentage of Participants With Events Included in the Safety Composite Endpoint of All-Cause Mortality and Disabling Stroke
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Assessment method [1]
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All subjects who are candidates for transcatheter aortic valve implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus Valve will be evaluated for enrollment in this study (as treated population) The Lotus Valve cohort is an ongoing study in it's 4 year follow up. The Lotus with Depth Guard cohort ended after 30 day follow up, therefore we have no data at 1 year.
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Timepoint [1]
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30 Days and 1 year
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Secondary outcome [2]
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In-hospital Mortality
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Assessment method [2]
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In-hospital mortality till discharge
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Timepoint [2]
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Duration of hospital stay, an expected average of 2 days
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Secondary outcome [3]
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Percentage of Participants With Events Included in the VARC Efficacy Composite Endpoint
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Assessment method [3]
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The VARC efficacy composite at 1 year, including all-cause mortality; all stroke (disabling and non-disabling); re-hospitalization for valve-related symptoms or worsening congestive heart failure (NYHA class III or IV); and prosthetic valve-related dysfunction (mean aortic valve gradient =20 mmHg, effective orifice area (EOA) =0.9-1.1 cm2 and/or Doppler velocity index (DVI) <0.35 m/s, AND/OR moderate or severe prosthetic valve aortic regurgitation)
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Timepoint [3]
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1 Year
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Secondary outcome [4]
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Patients With Valve Safety Composite Outcomes at 1 Year
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Assessment method [4]
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Time related valve safety composite outcomes at 1 year, including structural valve deterioration (valve-related dysfunction requiring repeat procedure [TAVI or SAVR]); prosthetic valve endocarditis; prosthetic valve thrombosis; thromboembolic events (e.g. stroke) and VARC bleeding, unless clearly unrelated to valve therapy based on investigator assessment (e.g. trauma).
The Lotus Valve cohort is an ongoing study in it's 4 year follow up. The Lotus with Depth Guard cohort ended after 30 day follow up, therefore we have no data at 1 year.
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Timepoint [4]
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1 Year
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Secondary outcome [5]
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Patients With VARC Safety Composite Outcomes at 30 Days
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Assessment method [5]
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Patients with VARC safety composite outcomes at 30 days. VARC safety composite endpoints are defined as:
Life-threatening bleeding
Acute kidney injury-Stage 2 or 3 (including renal replacement therapy)
Coronary artery obstruction requiring intervention
Major vascular complication
Valve-related dysfunction requiring repeat procedure (BAV, TAVI, or SAVR)
New conduction disturbances (LBBB, AVB, RBBB) and need for permanent pacemaker implantation
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Timepoint [5]
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30 Days
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Secondary outcome [6]
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Patients With Moderate and Severe Paravalvular Aortic Valve Regurgitation
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Assessment method [6]
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Grade of paravalvular aortic valve regurgitation pre-discharge as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory. The moderate and severe paravalvular aortic regurgitation rate will be compared to a pre-specified performance goal.
We don't have a powered analysis for the PVL for RESPOND study.
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Timepoint [6]
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Duration of hospital stay, an expected average of 2 days
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Eligibility
Key inclusion criteria
Subjects will be evaluated for eligibility by the clinical center's heart team per the
local standard of practice in accordance with the Directions for Use.
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Minimum age
No limit
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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
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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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
27/05/2014
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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
18/05/2021
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Sample size
Target
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Accrual to date
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Final
1064
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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Colombia
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Cali
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Colombia
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Floridablanca
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Finland
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Helsinki
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Finland
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Turku
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Germany
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NRW
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Germany
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Rheinland Pfalz
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Germany
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Bad Segeberg
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Germany
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Berlin
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Germany
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Bonn
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Germany
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Hamburg
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Germany
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Leipzig
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Germany
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Munich
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Germany
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Rostock
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Germany
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Siegburg
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Germany
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Ulm
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Israel
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Petach Tikva
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Italy
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Mi
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Italy
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PD
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Italy
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PI
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Italy
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Milano
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EM
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Rotterdam
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Hamilton
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Norway
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Bergen
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Poland
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Warsaw
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Madrid
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Spain
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Switzerland
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Bern
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England
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United Kingdom
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Brighton
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Leeds
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United Kingdom
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Leicester
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United Kingdom
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London
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United Kingdom
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Wolverhampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Boston Scientific Corporation
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of the RESPOND post market study is to collect real world clinical and device
performance outcomes data with the Lotus Valve System used in routine clinical practice to
demonstrate that the commercially available Lotus Valve System is a safe and effective
treatment for patients with severe calcific aortic stenosis.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02031302
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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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Nicolas Van Mieghem, MD
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Address
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Erasmus Medical Center
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02031302
Download to PDF