Clinical trial · Interventional
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
NCT02722551CI-TRIAL-00031081RELIEFwithdrawnPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Clinical study to evaluate the safety and performance of the CardiAQ-Edwards™ Transcatheter Mitral Valve
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mitral Valve Regurgitation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Transcatheter Mitral Valve Re-placement (TMVR) with the CardiAQ-Edwards™ Transcatheter Mitral Valve | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- Treatment with the CardiAQ-Edwards™ Transcatheter Mitral Valve (transapical or transseptal delivery)
- interventionNames
- Device: Transcatheter Mitral Valve Re-placement (TMVR) with the CardiAQ-Edwards™ Transcatheter Mitral Valve
Primary outcomes (2)
- measure
- Freedom from major adverse cardiac and cerebrovascular events
- timeFrame
- 30 days
- description
- MACCE; all-cause mortality, myocardial infarction, stroke, renal failure, and conversion to surgery per MVARC definitions
- measure
- Freedom from individual adverse events
- timeFrame
- 30 days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.