CardiAQ-Edwards™ Transcatheter Mitral Valve Replacement (TMVR) Study

Study Overview
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Brief Summary
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Clinical study to evaluate the safety and performance of the CardiAQ-Edwards™ Transcatheter Mitral Valve

Detailed Description
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The study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and performance of the CardiAQ-Edwards™ Transcatheter Mitral Valve with transapical and transseptal delivery systems in patients with degenerative or functional/ischemic mitral regurgitation.

Official Title
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The RELIEF Trial: REduction or eLimination of mItral rEgurgitation in Degenerative or Functional Mitral Regurgitation With the CardiAQ-Edwards™ Transcatheter Mitral Valve

Conditions
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Mitral Valve Regurgitation

Intervention / Treatment
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* Device: Transcatheter Mitral Valve Re-placement (TMVR) with the CardiAQ-Edwards™ Transcatheter Mitral Valve


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Treatment with the CardiAQ-Edwards™ Transcatheter Mitral Valve (transapical or transseptal delivery) | Device: Transcatheter Mitral Valve Re-placement (TMVR) with the CardiAQ-Edwards™ Transcatheter Mitral Valve<br>* Replacement of the mitral valve through a transcatheter approach<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from major adverse cardiac and cerebrovascular events | MACCE; all-cause mortality, myocardial infarction, stroke, renal failure, and conversion to surgery per MVARC definitions | 30 days | 
| Freedom from individual adverse events | % Freedom from individual adverse events | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New York Heart Association (NYHA) functional class | Number of patients with improvement in NYHA class | 30 days, 3 months, 6 months, 12 months | 
| Six minute walk test: | Increase in distance (m) from baseline | 30 days, 3 months, 6 months, 12 months | 
| Reduction in mitral regurgitation (MR) grade: | Number of patients with reduction in MR grade from baseline | 30 days, 3 months, 6 months, 12 months | 
| Technical success | Technical success per MVARC criteria (%) | 30 days, 3 months, 6 months, 12 months | 
| Device success | Device success per MVARC criteria (%) | 30 days, 3 months, 6 months, 12 months | 
| Procedure success | Procedure success per MVARC criteria (%) | 30 days, 3 months, 6 months, 12 months | 
| Patient success | Patient success per MVARC criteria (%) | 30 days, 3 months, 6 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mitral, Regurgitation, Insufficiency, Degenerative, Functional, Primary, Secondary, Organic, Transcatheter, TMVR, TMVI, Heart valve, Mitral valve, Transapical, Transfemoral, Transeptal, Severe