CardiAQ-Edwards™ Transcatheter Mitral Valve Replacement (TMVR) Study (RELIEF)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02722551 |
Recruitment Status :
Withdrawn
First Posted : March 30, 2016
Last Update Posted : January 9, 2018
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Condition or disease | Intervention/treatment | Phase |
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Mitral Valve Regurgitation | Device: Transcatheter Mitral Valve Re-placement (TMVR) with the CardiAQ-Edwards™ Transcatheter Mitral Valve | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | The RELIEF Trial: REduction or eLimination of mItral rEgurgitation in Degenerative or Functional Mitral Regurgitation With the CardiAQ-Edwards™ Transcatheter Mitral Valve |
Study Start Date : | November 2016 |
Estimated Primary Completion Date : | October 2019 |
Estimated Study Completion Date : | October 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: Treatment
Treatment with the CardiAQ-Edwards™ Transcatheter Mitral Valve (transapical or transseptal delivery)
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Device: Transcatheter Mitral Valve Re-placement (TMVR) with the CardiAQ-Edwards™ Transcatheter Mitral Valve
Replacement of the mitral valve through a transcatheter approach |
- Freedom from major adverse cardiac and cerebrovascular events [ Time Frame: 30 days ]MACCE; all-cause mortality, myocardial infarction, stroke, renal failure, and conversion to surgery per MVARC definitions
- Freedom from individual adverse events [ Time Frame: 30 days ]% Freedom from individual adverse events
- New York Heart Association (NYHA) functional class [ Time Frame: 30 days, 3 months, 6 months, 12 months ]Number of patients with improvement in NYHA class
- Six minute walk test: [ Time Frame: 30 days, 3 months, 6 months, 12 months ]Increase in distance (m) from baseline
- Reduction in mitral regurgitation (MR) grade: [ Time Frame: 30 days, 3 months, 6 months, 12 months ]Number of patients with reduction in MR grade from baseline
- Technical success [ Time Frame: 30 days, 3 months, 6 months, 12 months ]Technical success per MVARC criteria (%)
- Device success [ Time Frame: 30 days, 3 months, 6 months, 12 months ]Device success per MVARC criteria (%)
- Procedure success [ Time Frame: 30 days, 3 months, 6 months, 12 months ]Procedure success per MVARC criteria (%)
- Patient success [ Time Frame: 30 days, 3 months, 6 months, 12 months ]Patient success per MVARC criteria (%)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- NYHA ≥ II
- Moderate/severe or severe mitral regurgitation
- Prohibitive risk for open-heart surgery
- Meets anatomical criteria
Exclusion Criteria:
- Unsuitable anatomy
- Need for emergent or urgent surgery
- Prior mechanical aortic valve replacement
- Any prior surgical or transcatheter repair (excluding balloon valvuloplasty) or replacement of the mitral valve
- Preexisting device in the left ventricular apex
- Clinically significant, untreated coronary artery disease
- Limited life expectancy (< 12 months)
- Active infection

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02722551
Canada, British Columbia | |
St. Paul's Hospital, University of British Columbia | |
Vancouver, British Columbia, Canada, V6Z 1Y6 | |
Canada, Ontario | |
St. Michael's Hospital | |
Toronto, Ontario, Canada, M5B 1W8 | |
Centre Toronto General Hospital | |
Toronto, Ontario, Canada, M5G 2C4 | |
Canada | |
Centre de recherche Institut Universitaire de Cardiologie et de Pneumologie de Québec (CRIUCPQ) | |
Quebec, Canada, G1V 4G5 | |
Denmark | |
Rigshospitalet | |
Copenhagen, Denmark, 2100 | |
France | |
Centre Hospitalier Régional Universitaire de Lille | |
Lille, France, 59000 | |
Germany | |
Kerckhoff-Klinik GmbH | |
Bad Nauheim, Germany, 61231 | |
Deutsche Herzzentrum Berlin | |
Berlin, Germany, 13353 | |
University Heart Centre | |
Hamburg, Germany, 20146 | |
Herzzentrum der UniKlinik Köln | |
Köln, Germany, 50937 | |
Leipzig Herzzentrum | |
Leipzig, Germany, 04289 | |
Italy | |
Ospedale San Raffaele | |
Milano, Italy, 20132 | |
Universita di Roma Tor Vergata | |
Roma, Italy, 00133 | |
Netherlands | |
Erasmus Medical Centre | |
Rotterdam, Netherlands, 3015 CE | |
Switzerland | |
InselSpital Bern | |
Bern, Switzerland, 3010 |
Principal Investigator: | Lars Sondergaard | The Rigshospitalet, Copenhagen, Denmark |
Responsible Party: | Edwards Lifesciences |
ClinicalTrials.gov Identifier: | NCT02722551 |
Other Study ID Numbers: |
2015-14 |
First Posted: | March 30, 2016 Key Record Dates |
Last Update Posted: | January 9, 2018 |
Last Verified: | January 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Mitral Regurgitation Insufficiency Degenerative Functional Primary Secondary Organic Transcatheter |
TMVR TMVI Heart valve Mitral valve Transapical Transfemoral Transeptal Severe |
Mitral Valve Insufficiency Heart Valve Diseases Heart Diseases Cardiovascular Diseases |