Brief Title
A Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: The CHOICE Trial
Official Title
A Randomized Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: Medtronic CoreValve Versus Edwards SAPIEN XT (The CHOICE Trial)
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:
1. Successful vascular access, delivery and deployment of the device and successful
retrieval of the delivery system,
2. Correct position of the device in the proper anatomical location,
3. 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
4. Only one valve implanted in the proper anatomical location.
Secondary endpoints:
- 30-day-combined safety endpoint which is a combined endpoint defined by VARC as:
1. All cause mortality,
2. Major stroke,
3. Life threatening (or disabling) bleeding,
4. Acute kidney injury-Stage 3 (including renal replacement therapy),
5. Periprocedural myocardial infarction,
6. Major vascular complications and
7. Repeat procedure for valve-related dysfunction (surgical or interventional
therapy). *
- Combined efficacy endpoint at 1 year which is a composite endpoint defined by VARC as:
1. All cause mortality between 30 days and one year,
2. Failure of current therapy for aortic stenosis, requiring hospitalization for
symptoms of valve-related or cardiac decompensation and
3. Prosthetic heart valve dysfunction (aortic valve area < 1.2 cm2 and mean aortic
valve gradient > 20 mmHg or peak velocity > 3 m/s or moderate or severe prosthetic
valve AR). *
- Cardiovascular mortality as defined by VARC at 1 month, 6 and 12 months. *
- Major adverse cardiovascular and cerebrovascular events (MACCE): myocardial infarction,
cardiac or vascular surgery and stroke at 30 days, 6 & 12 months.
- Rehospitalization for heart failure at 12 months
- Quality of life (assessed with the Euro5Qual-questionnaire) at 12 months
- NYHA-class improvement at 30 days, 6 and 12 months
- Vascular complication as defined by VARC at 30 days.
- Post-procedural pacemaker implantation at 1 month
- Major or minor Bleeding at 30 days as defined be VARC.
Study Type
Interventional
Primary Outcome
'Device success' as recently defined by the Valve Academic Research Consortium
Secondary Outcome
VARC-defined combined safety endpoint
Condition
Aortic Stenosis
Intervention
Transcatheter Aortic Valve Implantation (TAVI)
Study Arms / Comparison Groups
TAVI with Edwards Sapien XT valve
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
241
Start Date
March 2012
Completion Date
December 2018
Primary Completion Date
December 2013
Eligibility Criteria
Inclusion Criteria:
1. Severe aortic valve stenosis defined as aortic valve area (AVA) ≤ 1cm2 or 0.6 cm2/m2
2. Presence of clinical symptoms defined as New York Heart Association (NYHA) functional
class ≥ 2
3. 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)
4. Native aortic valve annulus measuring 20-25 mm
5. Patients must be suitable for a transfemoral vascular access
6. The patient signing a written informed consent prior to intervention
Exclusion Criteria:
1. Life expectancy < 12 months due to co-morbid conditions
2. 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)
3. Pre-existing aortic bioprosthesis
4. Cardiogenic shock or hemodynamic instability
5. History of, or active endocarditis
6. Contraindications for a transfemoral access
7. Active peptic ulcer or upper gastro-intestinal bleeding within the prior 3 months.
8. Hypersensitivity or contraindication to aspirin, heparin or clopidogrel
9. Active infection requiring antibiotic treatment
10. An elective surgical procedure is planned that would necessitate interruption of
thienopyridines during the first 3 months post-enrolment
11. Patients actively participating in another drug or device investigational study and
have not yet completed the primary endpoint follow-up period
Gender
All
Ages
75 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Mohamed Abdel-Wahab, MD, ,
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT01645202
Organization ID
SK 107 -- 012/12 (II)
Responsible Party
Sponsor
Study Sponsor
Segeberger Kliniken GmbH
Study Sponsor
Mohamed Abdel-Wahab, MD, Principal Investigator, Herzzentrum, Segeberger Kliniken, Bad Segeberg, Germany
Verification Date
February 2019