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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Mitral Regurgitation

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Vanessa Gallois; Phone Number: +33 6 68 77 34 77; Email: vgallois@highlifemed.com

Study Locations

• Germany
  • Ulm
    • Ulm, Ulm, Germany, 89081
      • Universitätsklinikum Ulm
      • Contact: Wolfgang Rottbauer, MD; Phone Number: +49 731 500 45001; Email: sekretariat.rottbauer@uniklinik-ulm.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Commercial patients; That meet the criteria as outlined in the IFU, and who are scheduled to have the HighLife procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural Mortality	Where patient died during the procedure before exiting the procedure room	At exit from the procedure room
All-cause mortality	Patient death due to any cause	30 days, 6 months, 12 months, 1, 2, and 3 year
Reoperation	To include conversion to surgery, reintervention to surgery or non-surgical procedure	30 days
Disabling stroke	Meeting the criteria of disabling versus non-disabling stroke, as defined per MVARC guidelines, to include if ischemic or hemorrhagic	30 days, 6 months, 1, 2, 3 years
New onset conduction disturbance in the heart	This would be a heart conduction disturbance requiring a permanent pacemaker	30 days
Heart Failure Hospitalization	This would be a heart failure hospitalization, defined per the MVARC guidelines.	30 days, 6 and 12 months, 1, 2, 3 years
Freedom from left ventricular outflow tract obstruction (LVOTO)	Mean LVOT gradient ≥ 10 mmHg, as measured by transthoracic echo (TTE), and as analyzed by an independent Core Lab	30 days
Freedom from paravalvular leak (PVL), > 1+	This would be a leak around the HighLife valve, as assessed by transthoracic echo (TTE), and analyzed by an independent Core Lab	30 days
Annualized rate of Heart Failure Hospitalization (HFH)	An analysis performed by the biostatistician, to evaluate how often a patient experienced HFH in a year.	1, 2, 3 years
Total reduction of mitral regurgitation (MR) to 1+ or less	Measure by transthoracic echo (TTE), and as analyzed by an independent Core Lab	30 days, 6 months, 1, 2, 3 years
Long term durability of the HighLife valve	That the original HighLife device remains implanted, free from structural valve dysfunction (e.g. residual MR ≥2+ in the presence of morphological deterioration (e.g., torn, flail, or frozen leaflet, calcification, fracture, migration or embolization, device detachment), as assessed by transthoracic echo (TTE) and analyzed by an independent Core Lab, or as adjudicated by a Clinical Events Committee (CEC).	3 years
KCCQ score (mean) improvement	Mean improvement in the KCCQ Quality of Life Questionnaire (short form), comparing Baseline to 1 year	1 year
Improvement in six minute walk test (6MWT)	Measuring the number of meters a patient can walk in 6 minutes, comparing Baseline to 1 year	1 year

Collaborators and Investigators

• Sponsor: HighLife SAS

Study record dates

Study Major Dates

• Study Start (Estimated): March 14, 2026
• Primary Completion (Estimated): April 15, 2029
• Study Completion (Estimated): April 15, 2031

Study Registration Dates

• First Submitted: January 30, 2026
• First Submitted That Met QC Criteria: February 6, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 6, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: HL-2026-01-PMR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: This will still need to be confirmed and discussed internally.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No