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

Edwards Lifesciences

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Mitral Valve Regurgitation

Treatments: Device: Transcatheter Mitral Valve Re-placement (TMVR) with the CardiAQ-Edwards™ Transcatheter Mitral Valve

Study type: Interventional

Funder types: Industry

Identifiers

NCT02722551

2015-14 (Other Identifier)

Details and patient eligibility

About

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

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Treatment

Experimental group

Description:

Treatment with the CardiAQ-Edwards™ Transcatheter Mitral Valve (transapical or transseptal delivery)

Treatment:

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