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

Edwards Lifesciences

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Mitral Valve Regurgitation

Interventions

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

Replacement of the mitral valve through a transcatheter approach

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (15)

St. Paul's Hospital, University of British Columbia

Vancouver, British Columbia, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

Centre Toronto General Hospital

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Freedom from major adverse cardiac and cerebrovascular events

MACCE; all-cause mortality, myocardial infarction, stroke, renal failure, and conversion to surgery per MVARC definitions

Time frame: 30 days

Freedom from individual adverse events

% Freedom from individual adverse events

Time frame: 30 days