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NOT YET RECRUITING

NCT07409285

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

Sponsor: HighLife SAS

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

150

Start Date

2026-03-14

Completion Date

2031-04-15

Last Updated

2026-02-13

Healthy Volunteers

Conditions

Mitral Regurgitation

Inclusion Criteria: Participants must fulfill all following inclusion criteria in order to be included in the post market registry: 1. Participant is indicated for the HighLife TSMVR system per the current approved Instructions For Use (IFU) * Participant (≥ 18 years age) with severe or moderately severe mitral valve regurgitation (MR) due to primary (i.e. degenerative) and/or secondary (i.e. functional MR. * Left Ventricular Ejection Fraction (LVEF) ≥ 30% * Left ventricular end-diastolic dimension (LVEDD) ≤ 70 mm 2. Based on the assessment of the local multidisciplinary heart team, the participant is: 1. unsuitable for heart surgery (mitral valve repair or replacement) 2. unsuitable for treatment with transcatheter edge-to-edge repair (complex TEER anatomy) 3. 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: Participants will be excluded from the post market registry as per the current approved Instructions For Use (IFU) if any of the following criteria is met: 1. Significantly calcified mitral valves; 2. Severe mitral annular calcification 3. Narrow femoral arteries that don't allow the passage of 18F sheaths; 4. More than 80 cm between the aortic valve and the femoral access; 5. Allergies to TSMV or SAI components (bovine tissue, Nitinol, polyester, polyethylene, PTFE); 6. Intolerance to anticoagulation/antiplatelet regimens or procedural anticoagulation; 7. Active bacterial endocarditis or other active infections; 8. Allergies to contrast media; 9. Previous implanted aortic valve prosthesis; 10. Evidence of intracardiac mass, thrombus, or vegetation. 11. Participant enrolled in another clinical study that may impact the follow-up or results of this study. 12. Participant has other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, may limit the patient's ability to participate in the clinical study or to comply with follow-up requirements. 13. Tricuspid valve disease requiring intervention

Locations (1)

Universitätsklinikum Ulm

Ulm, Ulm, Germany