Not Yet RecruitingNot Applicable

The EMBRACE Registry: European Post-Market Registry for Catheter Based Mitral Valve Replacement

Germany150 participantsStarted 2026-03-14

Plain-language summary

Post-market registry for post-market surveillance, as part of the post-market plan, for the HighLife transcatheter, transseptal, mitral valve replacement system in a real world commercial setting.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Participant is indicated for the HighLife TSMVR system per the current approved Instructions For Use (IFU)
✓. Based on the assessment of the local multidisciplinary heart team, the participant is:
✓. unsuitable for heart surgery (mitral valve repair or replacement)
✓. unsuitable for treatment with transcatheter edge-to-edge repair (complex TEER anatomy)
✓. eligible to receive the HighLife TSMVR system per the current approved Instructions For Use (IFU) and as assessed by the local heart team

Exclusion criteria

✕. Significantly calcified mitral valves;
✕. Severe mitral annular calcification
✕. Narrow femoral arteries that don't allow the passage of 18F sheaths;
✕. More than 80 cm between the aortic valve and the femoral access;
✕. Allergies to TSMV or SAI components (bovine tissue, Nitinol, polyester, polyethylene, PTFE);
✕. Intolerance to anticoagulation/antiplatelet regimens or procedural anticoagulation;
✕. Active bacterial endocarditis or other active infections;
✕. Allergies to contrast media;

What they're measuring

Rate of Technical Success

Timeframe: At exit from procedure room

Rate of Device Success

Timeframe: 30 days

Primary Performance Endpoint

Timeframe: 30 days

Trial details

NCT IDNCT07409285

SponsorHighLife SAS

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2029-04-15

Contact for this trial

Vanessa Gallois

+33 6 68 77 34 77 vgallois@highlifemed.com

View on ClinicalTrials.gov More Mitral Regurgitation trials