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

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ClinicalTrials.gov Identifier: NCT01645202
Recruitment Status : Completed
First Posted : July 20, 2012
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
Segeberger Kliniken GmbH

Tracking Information
First Submitted Date  ICMJE June 6, 2012
First Posted Date  ICMJE July 20, 2012
Last Update Posted Date July 26, 2019
Study Start Date  ICMJE March 2012
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2012)
'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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2012)
  • 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).
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: The CHOICE Trial
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Aortic Stenosis
Intervention  ICMJE Procedure: Transcatheter Aortic Valve Implantation (TAVI)
Comparison of different types of valves
Other Name: Transcatheter Aortic Valve Replacement (TAVR)
Study Arms  ICMJE
  • Active Comparator: TAVI with Edwards Sapien XT valve
    Intervention: Procedure: Transcatheter Aortic Valve Implantation (TAVI)
  • Active Comparator: TAVI with Medtronic CoreValve
    Intervention: Procedure: Transcatheter Aortic Valve Implantation (TAVI)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 28, 2019)
241
Original Estimated Enrollment  ICMJE
 (submitted: July 17, 2012)
240
Actual Study Completion Date  ICMJE December 2018
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 75 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01645202
Other Study ID Numbers  ICMJE SK 107 -- 012/12 (II)
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Segeberger Kliniken GmbH
Study Sponsor  ICMJE Segeberger Kliniken GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mohamed Abdel-Wahab, MD Herzzentrum, Segeberger Kliniken, Bad Segeberg, Germany
Study Chair: Gert Richardt, MD Herzzentrum, Segeberger Kliniken, Bad Segeberg, Germany
PRS Account Segeberger Kliniken GmbH
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP