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Heart rhythm disorder may reshape valve before leaks start

NCT ID NCT07617974

Knowledge-focused Sponsor: Centro Cardiologico Monzino 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study uses 3D echocardiography to track changes in the tricuspid valve of 66 people with atrial fibrillation (AF) who do not yet have significant valve leakage. Researchers want to see if the valve's shape changes as AF becomes more persistent. The goal is to better understand how AF can lead to tricuspid regurgitation over time.

What this could mean

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

What this could lead to
If successful, this study could help doctors predict which AF patients are at risk for tricuspid regurgitation, potentially guiding earlier treatment.
What could go wrong
This is a small observational study, not a treatment trial. It only measures changes and cannot prove cause-and-effect or lead directly to new therapies.

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 66 people

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

Started

May 2026

Expected to finish

May 2027

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.

Who is studied

Patients suitable for enrolment in the present study are those with paroxysmal or persistent atrial fibrillation (AF) undergoing transthoracic echocardiography (TTE) prior to AF ablation and will be study group. The study group will be compared with the following control groups: a) patients with structurally normal hearts and no history of AF; b) patients with ≥ moderate atrial functional tricuspid regurgitation and AF, in the absence of significant left-sided valvular disease or prior valvular surgery.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Consecutive patients with atrial fibrillation (paroxysmal or persistent) undergoing transthoracic echocardiography (TTE) prior to AF ablation with acquisition of a 3D TV dataset. Eligible for enrollment in the control group will be: 1. all consecutive patients with structurally normal hearts and no history of AF or; 2. moderate atrial functional tricuspid regurgitation and AF, in the absence of significant left-sided valvular disease or prior valvular surgery. Exclusion Criteria: * Moderate or greater TR assessed using a multiparametric approach; * Arrhythmias other than AF; * Prior AF ablations; * Rapid ventricular response (average HR \>110 bpm) during baseline TTE; * Inadequate image quality

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Conditions

The condition(s) this trial relates to.

atrial fibrillation tricuspid valve insufficiency

As listed by the trial registrant

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

Atrial fibrillation (AF) Tricuspid regurgitation (TR)

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

  • Centro Cardiologico Monzino; IRCCS

    RECRUITING

    Milan, Milan, 20133, Italy

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