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

Phase 1

Withdrawn

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

• Registration Number: NCT02722551
• Lead Sponsor: Edwards Lifesciences

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2016-03-01
• Study First Submitted QC: 2016-03-24
• Study First Posted: 2016-03-30
• Study Start: 2016-11
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-05
• Last Update Posted: 2018-01-09
• Primary Completion: 2019-10
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Transcatheter Mitral Valve Re-placement (TMVR) with the CardiAQ-Edwards™ Transcatheter Mitral Valve	Treatment with the CardiAQ-Edwards™ Transcatheter Mitral Valve (transapical or transseptal delivery)

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (15)

St. Paul's Hospital, University of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada

Erasmus Medical Centre; 🇳🇱 Rotterdam, Netherlands

Centre de recherche Institut Universitaire de Cardiologie et de Pneumologie de Québec (CRIUCPQ); 🇨🇦 Quebec, Canada

Kerckhoff-Klinik GmbH; 🇩🇪 Bad Nauheim, Germany

Centre Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada

Centre Hospitalier Régional Universitaire de Lille; 🇫🇷 Lille, France

Ospedale San Raffaele; 🇮🇹 Milano, Italy

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

Deutsche Herzzentrum Berlin; 🇩🇪 Berlin, Germany

Herzzentrum der UniKlinik Köln; 🇩🇪 Köln, Germany

InselSpital Bern; 🇨🇭 Bern, Switzerland

Universita di Roma Tor Vergata; 🇮🇹 Roma, Italy

University Heart Centre; 🇩🇪 Hamburg, Germany

Leipzig Herzzentrum; 🇩🇪 Leipzig, Germany

Rigshospitalet; 🇩🇰 Copenhagen, Denmark