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
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Sponsor:
Segeberger Kliniken GmbH
Information provided by (Responsible Party):
Segeberger Kliniken GmbH
Tracking Information | |||||||
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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 |
'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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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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:
Secondary endpoints:
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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 |
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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)
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
241 | ||||||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 | ||||||
Current Responsible Party | Segeberger Kliniken GmbH | ||||||
Original Responsible Party | Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH | ||||||
Current Study Sponsor ICMJE | Segeberger Kliniken GmbH | ||||||
Original Study Sponsor ICMJE | Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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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 |