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

Primary Purpose

Mitral Valve Regurgitation

Status

Withdrawn

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Mitral Valve Regurgitation focused on measuring Mitral, Regurgitation, Insufficiency, Degenerative, Functional, Primary, Secondary, Organic, Transcatheter, TMVR, TMVI, Heart valve, Mitral valve, Transapical, Transfemoral, Transeptal, Severe

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

St. Paul's Hospital, University of British Columbia
St. Michael's Hospital
Centre Toronto General Hospital
Centre de recherche Institut Universitaire de Cardiologie et de Pneumologie de Québec (CRIUCPQ)
Rigshospitalet
Centre Hospitalier Régional Universitaire de Lille
Kerckhoff-Klinik GmbH
Deutsche Herzzentrum Berlin
University Heart Centre
Herzzentrum der UniKlinik Köln
Leipzig Herzzentrum
Ospedale San Raffaele
Universita di Roma Tor Vergata
Erasmus Medical Centre
InselSpital Bern

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

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

Outcomes

Primary Outcome Measures

Freedom from major adverse cardiac and cerebrovascular events

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

Freedom from individual adverse events

% Freedom from individual adverse events

Secondary Outcome Measures

New York Heart Association (NYHA) functional class

Number of patients with improvement in NYHA class

Six minute walk test:

Increase in distance (m) from baseline

Reduction in mitral regurgitation (MR) grade:

Number of patients with reduction in MR grade from baseline

Technical success

Technical success per MVARC criteria (%)

Device success

Device success per MVARC criteria (%)

Procedure success

Procedure success per MVARC criteria (%)

Patient success

Patient success per MVARC criteria (%)

Full Information

NCT ID

NCT02722551

First Posted

March 1, 2016

Last Updated

January 5, 2018

Sponsor

Edwards Lifesciences

1. Study Identification

Unique Protocol Identification Number

NCT02722551

Brief Title

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

Acronym

RELIEF

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 Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Withdrawn

Study Start Date

November 2016 (undefined)

Primary Completion Date

October 2019 (Anticipated)

Study Completion Date

October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Edwards Lifesciences

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mitral Valve Regurgitation

Keywords

Mitral, Regurgitation, Insufficiency, Degenerative, Functional, Primary, Secondary, Organic, Transcatheter, TMVR, TMVI, Heart valve, Mitral valve, Transapical, Transfemoral, Transeptal, Severe

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

Replacement of the mitral valve through a transcatheter approach

Primary Outcome Measure Information:

Title

Freedom from major adverse cardiac and cerebrovascular events

Description

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

Time Frame

30 days

Title

Freedom from individual adverse events

Description

% Freedom from individual adverse events

Time Frame

30 days

Secondary Outcome Measure Information:

Title

New York Heart Association (NYHA) functional class

Description

Number of patients with improvement in NYHA class

Time Frame