A Randomized Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: Medtronic CoreValve Versus Edwards SAPIEN XT (The CHOICE Trial)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Segeberger Kliniken GmbH
- Enrollment
- 241
- Locations
- 2
- Primary Endpoint
- 'Device success' as recently defined by the Valve Academic Research Consortium
Study Overview
Brief Summary
A randomized controlled multicenter study comparing the acute hemodynamic performance of the Edwards Sapien XT and the Medtronic CoreValve transcatheter heart valves in high risk patients with severe symptomatic aortic stenosis.
Detailed Description
Study design: randomized open-label multicenter
Primary endpoint:
'Device success' as recently defined by VARC which is a 'technical' composite endpoint including:
- Successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system,
- Correct position of the device in the proper anatomical location,
- Intended performance of the prosthetic heart valve (aortic valve area > 1.2 cm2 and mean aortic valve gradient < 20 mmHg or peak velocity < 3 m/s, without moderate or severe prosthetic valve AR) and
- Only one valve implanted in the proper anatomical location.
Secondary endpoints:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 75 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Severe aortic valve stenosis defined as aortic valve area (AVA) ≤ 1cm2 or 0.6 cm2/m2
- •Presence of clinical symptoms defined as New York Heart Association (NYHA) functional class ≥ 2
- •Age > 75 years and/or Logistic EuroSCORE ≥ 20% and/or STS risk score ≥ 10% and/or contraindication to conventional surgical aortic valve replacement (porcelain aorta, previous chest radiation, chest deformation)
- •Native aortic valve annulus measuring 20-25 mm
- •Patients must be suitable for a transfemoral vascular access
- •The patient signing a written informed consent prior to intervention
Exclusion Criteria
- •Life expectancy < 12 months due to co-morbid conditions
- •Native aortic valve annulus < 20 mm and > 25 mm (this could be amended if further valve sizes for the transfemoral approach become available for both prostheses during the study period)
- •Pre-existing aortic bioprosthesis
- •Cardiogenic shock or hemodynamic instability
- •History of, or active endocarditis
- •Contraindications for a transfemoral access
- •Active peptic ulcer or upper gastro-intestinal bleeding within the prior 3 months.
- •Hypersensitivity or contraindication to aspirin, heparin or clopidogrel
- •Active infection requiring antibiotic treatment
- •An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 3 months post-enrolment
- •Patients actively participating in another drug or device investigational study and have not yet completed the primary endpoint follow-up period
Arms & Interventions
TAVI with Edwards Sapien XT valve
Intervention: Transcatheter Aortic Valve Implantation (TAVI) (Procedure)
TAVI with Medtronic CoreValve
Intervention: Transcatheter Aortic Valve Implantation (TAVI) (Procedure)
Outcomes
Primary Outcomes
'Device success' as recently defined by the Valve Academic Research Consortium
Time Frame: Immediately after the procedure
Device success is a 'technical' composite endpoint including successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system, correct position of the device in the proper anatomical location, intended performance of the prosthetic heart valve (aortic valve area \> 1.2 cm2 and mean aortic valve gradient \< 20 mmHg or peak velocity \< 3 m/s, without moderate or severe prosthetic valve AR) and only one valve implanted in the proper anatomical location.
Secondary Outcomes
- VARC-defined combined safety endpoint(30 days)
- VARC-defined combined efficacy endpoint(1 year)