Mitral RegurgitationEMBRACENCT07409285
The EMBRACE Registry: European Post-Market Registry for Catheter Based Mitral Valve Replacement
An observational study of Mitral Regurgitation, run by HighLife SAS at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- 14 Mar 2026to 15 Apr 2031
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
Universitätsklinikum Ulm
Ulm, Ulm, 89081
Wolfgang Rottbauer, MD, +49 731 500 45001, sekretariat.rottbauer@uniklinik-ulm.de
About this study
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
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Commercial patients | That meet the criteria as outlined in the IFU, and who are scheduled to have the HighLife procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 30 days
Secondary outcomes (13)
Procedural Mortality
Where patient died during the procedure before exiting the procedure room
Measured: At exit from the procedure room
All-cause mortality
Patient death due to any cause
Measured: 30 days, 6 months, 12 months, 1, 2, and 3 year
Reoperation
To include conversion to surgery, reintervention to surgery or non-surgical procedure
Measured: 30 days
Disabling stroke
Meeting the criteria of disabling versus non-disabling stroke, as defined per MVARC guidelines, to include if ischemic or hemorrhagic
Measured: 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
Measured: 30 days
Heart Failure Hospitalization
This would be a heart failure hospitalization, defined per the MVARC guidelines.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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).
Measured: 3 years
KCCQ score (mean) improvement
Mean improvement in the KCCQ Quality of Life Questionnaire (short form), comparing Baseline to 1 year
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start14 Mar 2026 (estimated)
- Primary completion15 Apr 2029 (estimated)
- Study completion15 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- HighLife SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409285
- Sponsor's protocol ID
- HL-2026-01-PMR
- Acronym
- EMBRACE
- Status last verified
- Feb 2026
- First submitted
- 30 Jan 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This will still need to be confirmed and discussed internally.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The EMBRACE Registry: European Post-Market Registry for Catheter Based Mitral Valve Replacement
- ClinicalTrials.gov ID
- NCT07409285
- Acronym / sponsor ID
- EMBRACE / HL-2026-01-PMR
- Conditions
- Mitral Regurgitation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- HighLife SASIndustry (pharma, biotech, devices)
- Study start
- 14 Mar 2026 (estimated)
- Primary completion
- 15 Apr 2029 (estimated)
- Study completion
- 15 Apr 2031 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Commercial patients | – | –That meet the criteria as outlined in the IFU, and who are scheduled to have the HighLife procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of Technical Success
Time frame: At exit from procedure room
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
Rate of Device Success
Time frame: 30 days
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
Primary Performance Endpoint
Time frame: 30 days
Rate of Total Mitral Regurgitation reduction to 1+ or less assessed by transthoracic echo (TTE), and as analyzed by an independent Core Lab
13 secondary outcomes
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
Improvement in six minute walk test (6MWT)
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: Undecided. This will still need to be confirmed and discussed internally.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Regurgitation, run by HighLife SAS at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vanessa Gallois (+33 6 68 77 34 77, vgallois@highlifemed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Technical Success (time frame: At exit from procedure room). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.