A Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: The CHOICE Trial (CHOICE)

July 24, 2019 updated by: Segeberger Kliniken GmbH

A Randomized Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: Medtronic CoreValve Versus Edwards SAPIEN XT (The CHOICE Trial)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

241

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Schleswig-Holstein
      • Bad Segeberg, Schleswig-Holstein, Germany, 23795
        • Segeberger Kliniken GmbH / Herzzentrum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TAVI with Edwards Sapien XT valve
Procedure: Transcatheter Aortic Valve Implantation (TAVI)
Comparison of different types of valves
Other Names:
  • Transcatheter Aortic Valve Replacement (TAVR)
Active Comparator: TAVI with Medtronic CoreValve
Procedure: Transcatheter Aortic Valve Implantation (TAVI)
Comparison of different types of valves
Other Names:
  • Transcatheter Aortic Valve Replacement (TAVR)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
'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.
Immediately after the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VARC-defined combined safety endpoint
Time Frame: 30 days
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).
30 days
VARC-defined combined efficacy endpoint
Time Frame: 1 year
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)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Segeberger Kliniken GmbH

Investigators

  • Principal Investigator: Mohamed Abdel-Wahab, MD, Herzzentrum, Segeberger Kliniken, Bad Segeberg, Germany
  • Study Chair: Gert Richardt, MD, Herzzentrum, Segeberger Kliniken, Bad Segeberg, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

June 6, 2012

First Submitted That Met QC Criteria

July 17, 2012

First Posted (Estimate)

July 20, 2012

Study Record Updates

Last Update Posted (Actual)

July 26, 2019

Last Update Submitted That Met QC Criteria

July 24, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SK 107 -- 012/12 (II)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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