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

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

Status

Withdrawn

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02722551

Acronym

RELIEF

Enrollment

Registered

2016-03-30

Start date

2016-11-30

Completion date

2024-10-31

Last updated

2018-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Valve Regurgitation

Keywords

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

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.

Interventions

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

Replacement of the mitral valve through a transcatheter approach

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 (%)
New York Heart Association (NYHA) functional class	30 days, 3 months, 6 months, 12 months	Number of patients with improvement in NYHA class
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 (%)
Device success	30 days, 3 months, 6 months, 12 months	Device success per MVARC criteria (%)
Six minute walk test:	30 days, 3 months, 6 months, 12 months	Increase in distance (m) from baseline

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026