Not yet recruiting NCT07409285
The EMBRACE Registry: European Post-Market Registry for Catheter Based Mitral Valve Replacement
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Mitral Regurgitation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Rate of Technical Success [Time frame: At exit from procedure room]
- Rate of Device Success [Time frame: 30 days]
- Primary Performance Endpoint [Time frame: 30 days]
Secondary outcome measures (12)
- Procedural Mortality [Time frame: At exit from the procedure room]
- All-cause mortality [Time frame: 30 days, 6 months, 12 months, 1, 2, and 3 year]
- Reoperation [Time frame: 30 days]
- Disabling stroke [Time frame: 30 days, 6 months, 1, 2, 3 years]
- New onset conduction disturbance in the heart [Time frame: 30 days]
- Heart Failure Hospitalization [Time frame: 30 days, 6 and 12 months, 1, 2, 3 years]
- Freedom from left ventricular outflow tract obstruction (LVOTO) [Time frame: 30 days]
- Freedom from paravalvular leak (PVL), > 1+ [Time frame: 30 days]
- Annualized rate of Heart Failure Hospitalization (HFH) [Time frame: 1, 2, 3 years]
- Total reduction of mitral regurgitation (MR) to 1+ or less [Time frame: 30 days, 6 months, 1, 2, 3 years]
- Long term durability of the HighLife valve [Time frame: 3 years]
- KCCQ score (mean) improvement [Time frame: 1 year]
Eligibility criteria
Inclusion Criteria: Participants must fulfill all following inclusion criteria in order to be included in the post market registry:
- 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
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:
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Universitätsklinikum Ulm — Ulm
Identifiers
NCT: NCT07409285 · HL-2026-01-PMR