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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05149755




Registration number
NCT05149755
Ethics application status
Date submitted
24/11/2021
Date registered
8/12/2021

Titles & IDs
Public title
Evolut™ EXPAND TAVR II Pivotal Trial
Scientific title
Evolut™ EXPAND TAVR II Pivotal Trial
Secondary ID [1] 0 0
D00411092
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Moderate Aortic Valve Stenosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Medtronic Evolut PRO+ TAVR System, or Evolut FX TAVR System, and guideline-directed management and therapy (GDMT)

Experimental: Medtronic Evolut PRO+, or Evolut FX,TAVR System, & guideline-directed management & therapy (GDMT) - Medtronic Evolut PRO+ TAVR or Evolut FX TAVR Systems, \& guideline-directed management \& therapy

No intervention: Clinical site determined guideline-directed management and therapy (GDMT) alone - Clinical site determined guideline-directed management and therapy (GDMT) alone


Treatment: Devices: Medtronic Evolut PRO+ TAVR System, or Evolut FX TAVR System, and guideline-directed management and therapy (GDMT)
Patients will have a Transcatheter Aortic Valve Replacement (TAVR) with either an Evolut PRO+ TAVR, or Evolut FX TAVR, heart valve, and given clinical site-determined guideline-directed management and therapy (GDMT).
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite rate of all-cause mortality, all-stroke, life threatening or fatal bleeding, acute kidney injury, hospitalization due to device or procedure-related complication, or valve dysfunction requiring reintervention.
Timepoint [1] 0 0
30 days
Primary outcome [2] 0 0
Composite rate of all-cause mortality, heart failure hospitalization or event, or medical instability leading to aortic valve replacement or re-intervention.
Timepoint [2] 0 0
2 years
Secondary outcome [1] 0 0
Proportion of subjects alive and with moderately improved quality of life (= 10 points in KCCQ summary score from baseline)
Timepoint [1] 0 0
1 year
Secondary outcome [2] 0 0
Composite of all-cause mortality and heart failure hospitalizations or events.
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
Composite of all-cause mortality, all-stroke, or unplanned CV hospitalizations
Timepoint [3] 0 0
2 years
Secondary outcome [4] 0 0
Heart failure hospitalizations or events.
Timepoint [4] 0 0
2 years
Secondary outcome [5] 0 0
All-cause mortality
Timepoint [5] 0 0
2 years
Secondary outcome [6] 0 0
Unplanned cardiovascular hospitalizations
Timepoint [6] 0 0
2 years
Secondary outcome [7] 0 0
Days alive and free of unplanned cardiovascular hospitalizations
Timepoint [7] 0 0
2 years

Eligibility
Key inclusion criteria
Key

o Moderate AS, defined as follows by transthoracic echo (TTE) as assessed by the ECL:

* AVA >1.0 cm² and <1.5cm²; or
* AVA = 1.0 cm² with AVAI > 0.6cm²/m² if BMI < 30 kg/m²: or
* AVA = 1.0 cm² with AVAI > 0.5cm²/m² if BMI = 30 kg/m²:

and

* Max aortic velocity = 3.0 m/sec. and < 4.0 m/sec. or
* Mean aortic gradient = 20mmHg and < 40.0 mmHg

Any of the following at-risk features:

* Symptoms of AS, defined as:
* NYHA = Class II, or
* Reduced functional capacity, defined as

* 6MWT < 300 meters, or
* < 85% of age-sex predicted METs on exercise tolerance testing (ETT)
* Documented heart failure event or hospitalization for heart failure within 1 calendar year prior to consent
* NT-proBNP = 600 pg/ml (or BNP = 80 pg/ml), or
* Persistent AF or Paroxysmal AF episode within 6 months prior to consent, or
* Elevated aortic valve calcium score (>1200 AU for females and > 2000 AU for males) as assessed by the MDCT core lab, or
* Any of the following by the qualifying TTE as assessed by the ECL:

* Global longitudinal strain =16% (absolute value), or
* E/e' = 14.0 (average of medial and lateral velocities), or
* Diastolic dysfunction = Grade II, or
* LVEF < 60%
* Stroke Volume Index < 35 ml/m²
* Anatomically suitable for transfemoral TAVR using the Medtronic Evolut PRO+ or Evolut FX system
* The subject and the treating physician agree the subject will return for all required follow-up visits

Key
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Age < 65 years
* LVEF = 20% by 2-D echo
* Class I indication for cardiac surgery
* Contraindication for placement of a bioprosthetic valve
* Documented history of cardiac amyloidosis

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2034
Actual
Sample size
Target
650
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [2] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment postcode(s) [2] 0 0
6150 - Murdoch
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Medtronic Cardiovascular
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul Sorajja, MD
Address 0 0
Allina Health System
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Hang Nguyen
Address 0 0
Country 0 0
Phone 0 0
+1765262832
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05149755