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Tiny trial tests catheter fix for leaky heart valves

NCT ID NCT07188233

Disease control Sponsor: HVR Cardio Oy Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This early study is testing a new device called CathHELIX that aims to repair a leaky mitral valve using a thin tube (catheter) instead of open-heart surgery. The trial will enroll just 5 people with moderate to severe mitral regurgitation who have symptoms like shortness of breath. The main goal is to see if the device can be safely placed and work as intended.

What this could mean

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

Active substance
CathHELIX Transcatheter Mitral Annuloplasty System (a device)
What this could lead to
If successful, this could offer a less invasive repair option for people with leaky mitral valves, potentially reducing symptoms and improving heart function.
What could go wrong
This is a very early feasibility study with only 5 people. The device may not work as intended, and risks include complications from the procedure or the need for emergency surgery.

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

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

About 5 people

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

Started

Nov 2024

Expected to finish

Jul 2026

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.

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: * Moderate to severe (3+) or severe (4+) functional mitral regurgitation * Left ventricular ejection fraction ≥30% * Symptomatic New York Heart Association (NYHA) Class II to IV). Exclusion Criteria: * Oxygen dependent for COPD * Active or suspected endocarditis * Severe symptomatic carotid stenosis * Has undergone heart transplantation. * Severe calcification of the mitral annulus or leaflets * Coronary sinus anatomy that may preclude proper treatment with the device

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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 valve regurgitation (degenerative or functional)

How to take part

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

  1. The places running it

    2 sites in 2 countries. 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

  • Tbilisi Heart and Vascular Clinic

    RECRUITING

    Tbilisi, Georgia, Georgia

  • Vilnius University Hospital, Santaros Klinikos, Public Institution

    RECRUITING

    Vilnius, Lithuania, Lithuania

More trials for these conditions

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