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

Mitral Valve Regurgitation Clinical Trial

— 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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02722551
• Other study ID #: 2015-14
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: March 1, 2016
• Last updated: January 5, 2018
• Start date: November 2016
• Est. completion date: October 2024

Study information

• Verified date: January 2018
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2024
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mitral Valve Insufficiency
• Mitral Valve Regurgitation

Intervention

Device:
• Transcatheter Mitral Valve Re-placement (TMVR) with the CardiAQ-Edwards™ Transcatheter Mitral Valve
Replacement of the mitral valve through a transcatheter approach

Locations

Country	Name	City	State
Canada	Centre de recherche Institut Universitaire de Cardiologie et de Pneumologie de Québec (CRIUCPQ)	Quebec
Canada	Centre Toronto General Hospital	Toronto	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	St. Paul's Hospital, University of British Columbia	Vancouver	British Columbia
Denmark	Rigshospitalet	Copenhagen
France	Centre Hospitalier Régional Universitaire de Lille	Lille
Germany	Kerckhoff-Klinik GmbH	Bad Nauheim
Germany	Deutsche Herzzentrum Berlin	Berlin
Germany	University Heart Centre	Hamburg
Germany	Herzzentrum der UniKlinik Köln	Köln
Germany	Leipzig Herzzentrum	Leipzig
Italy	Ospedale San Raffaele	Milano
Italy	Universita di Roma Tor Vergata	Roma
Netherlands	Erasmus Medical Centre	Rotterdam
Switzerland	InselSpital Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Countries where clinical trial is conducted

Canada,  Denmark,  France,  Germany,  Italy,  Netherlands,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from major adverse cardiac and cerebrovascular events	MACCE; all-cause mortality, myocardial infarction, stroke, renal failure, and conversion to surgery per MVARC definitions	30 days
Primary	Freedom from individual adverse events	% Freedom from individual adverse events	30 days
Secondary	New York Heart Association (NYHA) functional class	Number of patients with improvement in NYHA class	30 days, 3 months, 6 months, 12 months
Secondary	Six minute walk test:	Increase in distance (m) from baseline	30 days, 3 months, 6 months, 12 months
Secondary	Reduction in mitral regurgitation (MR) grade:	Number of patients with reduction in MR grade from baseline	30 days, 3 months, 6 months, 12 months
Secondary	Technical success	Technical success per MVARC criteria (%)	30 days, 3 months, 6 months, 12 months
Secondary	Device success	Device success per MVARC criteria (%)	30 days, 3 months, 6 months, 12 months
Secondary	Procedure success	Procedure success per MVARC criteria (%)	30 days, 3 months, 6 months, 12 months
Secondary	Patient success	Patient success per MVARC criteria (%)	30 days, 3 months, 6 months, 12 months