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New heart valve fix without open surgery under Real-World watch

NCT ID NCT07409285

Disease control Sponsor: HighLife SAS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This registry will follow 150 people with severe mitral regurgitation who receive the HighLife transcatheter mitral valve replacement system. The goal is to see how well the device works and how safe it is when used in everyday medical practice. Participants are treated according to standard instructions, and researchers will track outcomes like survival, valve function, and complications for up to 30 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HighLife transcatheter mitral valve replacement system
What this could lead to
If successful, this registry could confirm that the HighLife system is a safe and effective option for treating severe mitral regurgitation without open-heart surgery.
What could go wrong
This is a post-market registry, not a randomized trial, so results may be less definitive. Risks include serious complications like stroke, bleeding, or need for additional procedures.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Apr 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

mitral valve insufficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Mitral regurgitation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Universitätsklinikum Ulm

    Ulm, Ulm, 89081, Germany

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