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

Sponsor

Edwards Lifesciences (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT02722551

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Mitral Valve Regurgitation	Device: Transcatheter Mitral Valve Re-placement (TMVR) with the CardiAQ-Edwards™ Transcatheter Mitral Valve	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Nov 1, 2016

Anticipated Primary Completion Date :

Oct 1, 2019

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

New York Heart Association (NYHA) functional class [30 days, 3 months, 6 months, 12 months]
Number of patients with improvement in NYHA class
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 (%)
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 (%)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Paul's Hospital, University of British Columbia	Vancouver	British Columbia	Canada	V6Z 1Y6
2	St. Michael's Hospital	Toronto	Ontario	Canada	M5B 1W8
3	Centre Toronto General Hospital	Toronto	Ontario	Canada	M5G 2C4
4	Centre de recherche Institut Universitaire de Cardiologie et de Pneumologie de Québec (CRIUCPQ)	Quebec		Canada	G1V 4G5
5	Rigshospitalet	Copenhagen		Denmark	2100
6	Centre Hospitalier Régional Universitaire de Lille	Lille		France	59000
7	Kerckhoff-Klinik GmbH	Bad Nauheim		Germany	61231
8	Deutsche Herzzentrum Berlin	Berlin		Germany	13353
9	University Heart Centre	Hamburg		Germany	20146
10	Herzzentrum der UniKlinik Köln	Köln		Germany	50937
11	Leipzig Herzzentrum	Leipzig		Germany	04289
12	Ospedale San Raffaele	Milano		Italy	20132
13	Universita di Roma Tor Vergata	Roma		Italy	00133
14	Erasmus Medical Centre	Rotterdam		Netherlands	3015 CE
15	InselSpital Bern	Bern		Switzerland	3010