Clinical trial NCT02722551: CardiAQ-Edwards™ Transcatheter Mitral Valve Replacement (TMVR) Study
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
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Mitral Valve Regurgitation
Keywords: Mitral
Regurgitation
Insufficiency
Degenerative
Functional
Primary
Secondary
Organic
Transcatheter
TMVR
TMVI
Heart valve
Mitral valve
Transapical
Transfemoral
Transeptal
Severe
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2016-03-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Freedom from major adverse cardiac and cerebrovascular events
timeFrame: 30 days
measure: Freedom from individual adverse events
timeFrame: 30 days
Secondary outcomes:
measure: New York Heart Association (NYHA) functional class
timeFrame: 30 days, 3 months, 6 months, 12 months
measure: Six minute walk test:
timeFrame: 30 days, 3 months, 6 months, 12 months
measure: Reduction in mitral regurgitation (MR) grade:
timeFrame: 30 days, 3 months, 6 months, 12 months
measure: Technical success
timeFrame: 30 days, 3 months, 6 months, 12 months
measure: Device success
timeFrame: 30 days, 3 months, 6 months, 12 months
measure: Procedure success
timeFrame: 30 days, 3 months, 6 months, 12 months
measure: Patient success
timeFrame: 30 days, 3 months, 6 months, 12 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St. Paul's Hospital, University of British Columbia
state: British Columbia
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Centre Toronto General Hospital
state: Ontario
city: Quebec
country: Canada
facility: Centre de recherche Institut Universitaire de Cardiologie et de Pneumologie de Québec (CRIUCPQ)
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Lille
country: France
facility: Centre Hospitalier Régional Universitaire de Lille
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik GmbH
city: Berlin
country: Germany
facility: Deutsche Herzzentrum Berlin
city: Hamburg
country: Germany
facility: University Heart Centre
city: Köln
country: Germany
facility: Herzzentrum der UniKlinik Köln
city: Leipzig
country: Germany
facility: Leipzig Herzzentrum
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Roma
country: Italy
facility: Universita di Roma Tor Vergata
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Centre
city: Bern
country: Switzerland
facility: InselSpital Bern
Study officials:
affiliation: The Rigshospitalet, Copenhagen, Denmark
name: Lars Sondergaard
role: PRINCIPAL_INVESTIGATOR
References: