Tiny device could fix leaky heart valves without cutting chest open
NCT ID NCT07671820
First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
This early trial tests a new device called Anchord that repairs leaky mitral valves without open-heart surgery. It will include 5 people with severe valve leakage who are too high-risk for standard surgery. The goal is to see if the device is safe and can reduce the leak, improving symptoms like shortness of breath.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Anchord Mitral Chordal Repair device
- What this could lead to
- If it works, this could offer a less invasive option for people with leaky heart valves who are too high-risk for open-heart surgery.
- What could go wrong
- This is a very early first-in-human trial with only 5 participants, so results may not apply broadly. The device could fail to reduce the leak or cause complications like infection or device movement.
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.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 5 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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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.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Severe symptomatic degenerative mitral regurgitation (grade 3+) * High surgical risk for open-heart mitral valve repair or replacement * Suitable anatomy for transcatheter chordal repair as determined by the treating physician * Ability to undergo required echocardiographic and fluoroscopic imaging * Ability to provide informed consent Exclusion Criteria: * Active endocarditis or systemic infection * Severe left ventricular dysfunction (LVEF \<30%) * Significant non-mitral valvular disease requiring intervention * Severe mitral annular calcification (MAC) * Presence of intracardiac or femoral venous thrombus or thrombus in the inferior vena cava * Cerebrovascular events (TIA, CVA) or thromboembolic events within the previous 6 months. * Renal insufficiency * Inability to undergo required imaging or access * Inability to tolerate standard anticoagulation or antithrombotic regimen * Rheumatic mitral valve disease * Co-morbid condition limiting life expectancy or study completion * Pregnancy * Participation in another clinical trial * Previous device treatment for MR.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
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Other studies related to the condition(s) this trial covers.
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