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

NCT07409285 | Not Yet Recruiting

• 1 other identifier: HL-2026-01-PMR
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mitral Regurgitation

Outcome Measures

Primary Outcomes (3)

• Rate of Technical Success

  To measure the rate of subjects that meet the definition of Technical success defined as an alive participant at exit from procedure room, with all of the following: * Successful vascular access, delivery and retrieval of the HighLife delivery systems * Deployment and correct positioning of the HighLife 28mm bio-prosthesis * Freedom from additional emergency surgery or re-intervention related to the device or access procedure, that occurred (was initiated) during the procedure

  At exit from procedure room

• Rate of Device Success

  To measure the rate of subjects that meet the definition of Device safety, defined as the freedom of major adverse events at 30 days, as follows: * All-cause mortality * Myocardial infarction * Major/disabling stroke * Life-threatening bleeding (MVARC scale) * Major access and vascular complications * Stage 2 or 3 acute kidney injury (includes dialysis) * Any mitral valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention * Severe hypotension, heart failure or respiratory failure requiring intravenous vasopressors or invasive or mechanical heart failure treatments such as ultrafiltration or hemodynamic assist devices, including intra-aortic balloon pumps or left ventricular or biventricular assist devices for ≥ 48 hours, or prolonged intubation for ≥ 48 hours

  30 days

• Primary Performance Endpoint

  Rate of Total Mitral Regurgitation reduction to 1+ or less assessed by transthoracic echo (TTE), and as analyzed by an independent Core Lab

  30 days

Secondary Outcomes (13)

• Procedural Mortality

  At exit from the procedure room

• All-cause mortality

  30 days, 6 months, 12 months, 1, 2, and 3 year

• Reoperation

  30 days

• Disabling stroke

  30 days, 6 months, 1, 2, 3 years

• New onset conduction disturbance in the heart

  30 days

Study Arms (1)

Commercial patients

That meet the criteria as outlined in the IFU, and who are scheduled to have the HighLife procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Per Instruction For Use (IFU): Adult patients suffering from symptomatic moderate-severe or severe MR who are unsuitable for surgical repair/replacement and transcatheter edge-to-edge repair, as deemed by a multi-disciplinary heart team.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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;
• Previous implanted aortic valve prosthesis;
• Evidence of intracardiac mass, thrombus, or vegetation.
• Participant enrolled in another clinical study that may impact the follow-up or results of this study.
• 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.
• Tricuspid valve disease requiring intervention

Sponsors & Collaborators

• HighLife SAS: lead

Study Sites (1)

Universitätsklinikum Ulm

Ulm, Ulm, 89081, Germany

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Vanessa Gallois

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 13, 2026
• Study Start: March 14, 2026
• Primary Completion (Estimated): April 15, 2029
• Study Completion (Estimated): April 15, 2031
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

DE (1)