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A simple pressure reading may expose hidden mitral valve leakage after keyhole repair

NCT ID NCT07798037

Knowledge-focused Sponsor: Hippocration General Hospital 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

This study tests whether the pressure gradient across an intentionally created atrial septal defect, measured right after a minimally invasive mitral valve repair called M-TEER, can indicate how much mitral regurgitation remains. Researchers will compare this gradient with echocardiographic and hemodynamic measurements in 100 patients undergoing M-TEER. The goal is to find a reliable cutoff that identifies mild versus moderate-or-greater residual leakage, which could improve how doctors assess procedural success.

What this could mean

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

Active substance
M-TEER procedure with hemodynamic and echocardiographic assessment
What this could lead to
If the iASD gradient reliably reflects residual mitral regurgitation, doctors could better judge procedural success and guide follow-up care after M-TEER.
What could go wrong
This is an observational study, not a treatment trial. The marker may not prove accurate across different patients, and the findings may not change clinical practice without further validation.

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 100 people

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

Started

Sep 2024

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

40 to 90 years

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: * patients with high or prohibitive surgical risk and moderate-to-severe or severe symptomatic MR, despite the administration of maximally tolerated doses of guideline-directed medical therapy and, if appropriate, cardiac resynchronization therapy * patients undergoing M-TEER as a bridge to heart transplantation Exclusion Criteria: * Patients with post-procedural transmitral gradient ≥5 mmHg, * Patients with right-to-left shunt requiring iASD closure, * Patients, who decline to provide written informed consent.

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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.

Iatrogenic asd Mitral regurgitation

Contacts and locations

Locations

  • First Cardiology Department, Hippokration General Hospital

    Athens, 11521, Greece

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