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

January 5, 2018 updated by: Edwards Lifesciences

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1V 4G5
        • Centre de recherche Institut Universitaire de Cardiologie et de Pneumologie de Québec (CRIUCPQ)
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • St. Paul's Hospital, University of British Columbia
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital
      • Toronto, Ontario, Canada, M5G 2C4
        • Centre Toronto General Hospital
  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet
  • France
      • Lille, France, 59000
        • Centre Hospitalier Regional Universitaire de Lille
  • Germany
      • Bad Nauheim, Germany, 61231
        • Kerckhoff-Klinik GmbH
      • Berlin, Germany, 13353
        • Deutsche Herzzentrum Berlin
      • Hamburg, Germany, 20146
        • University Heart Centre
      • Köln, Germany, 50937
        • Herzzentrum der Uniklinik Köln
      • Leipzig, Germany, 04289
        • Leipzig Herzzentrum
  • Italy
      • Milano, Italy, 20132
        • Ospedale San Raffaele
      • Roma, Italy, 00133
        • Universita Di Roma Tor Vergata
  • Netherlands
      • Rotterdam, Netherlands, 3015 CE
        • Erasmus Medical Centre
  • Switzerland
      • Bern, Switzerland, 3010
        • Inselspital Bern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
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
Replacement of the mitral valve through a transcatheter approach

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Edwards Lifesciences

Investigators

  • Principal Investigator: Lars Sondergaard, The Rigshospitalet, Copenhagen, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

October 1, 2024

Study Registration Dates

First Submitted

March 1, 2016

First Submitted That Met QC Criteria

March 24, 2016

First Posted (Estimate)

March 30, 2016

Study Record Updates

Last Update Posted (Actual)

January 9, 2018

Last Update Submitted That Met QC Criteria

January 5, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-14 (assistance publique hopitaux de marseille)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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