An interventional study of ReValve System in Mitral Regurgitation, sponsored by ReValve Solutions Inc.. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by ReValve Solutions Inc. · Not applicable, Interventional, and Treatment
Prospective, single-arm, multicenter, non-randomized early feasibility study
This study will evaluate the safety and performance of the ReValve System for the treatment of patients with clinically significant symptomatic primary orsecondary mitral regurgitation who are at high, but not prohibitive, surgical risk for mitral valvesurgery and, who are deemed anatomically or technically unsuitable for transcatheter edge-to-edgerepair (TEER) by the multidisciplinary heart team (MDHT).
467 studies on the registry are indexed under Mitral Valve Insufficiency; 152 are open to participants now.
This study's planned enrollment of 10 is below the median of 60 across 279 interventional studies indexed under Mitral Valve Insufficiency.
Browse Mitral Valve Insufficiency studies →ReValve Solutions Inc. is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Device: ReValve System
ReValve System Mitral Valve Replacement Procedure
Primary Efficacy Endpoint
Procedural Success according to MVARC criteria All of the following must be present: Device Success: Absence of procedural mortality or stroke; proper placement and positioning of the device; freedom from unplanned surgical/interventional procedures related to device/access; and continued intended safety and performance. Absence of major device or procedure related serious adverse events: Death; stroke; life-threatening bleeding (MVARC scale); major vascular complications; major cardiac structural complications; Stage 2 or 3 acute kidney injury (includes new dialysis); myocardial infarction or coronary ischemia requiring PCI or CABG; severe hypotension, heart failure, or respiratory failure requiring IV pressors, mechanical heart failure treatments, or intubation ≥48 h; or any study valve dysfunction, migration, or thrombosis requiring surgery or repeat intervention.
Time frame: 30 Days
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Nov 2031, 60 months later.
Of 93 industry-sponsored interventional studies with no phase under Mitral Valve Insufficiency, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 144. This study's planned 60 months is close to that.
Counting every sponsor, half of 138 studies reached it within 56 months; a quarter within 25 and three quarters within 108.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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