What happens to the tricuspid valve in atrial fibrillation patients without strong valve leakage

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective observational study will follow adults with atrial fibrillation undergoing baseline and 1-year follow-up echocardiography. Researchers will measure tricuspid valve geometry with 3D imaging and AI-assisted analysis, alongside standard echo metrics and right heart strain, while tracking AF burden with Holter monitoring at baseline, 3 months, and 12 months. The primary goal is to compare 3D tricuspid annulus geometry between paroxysmal and persistent AF, and secondary goals include changes over time, development of moderate or greater TR, and relationships between AF burden and remodeling. Results will be contextualized against two control groups: structurally normal hearts without AF, and AF patients with moderate atrial functional TR but no significant left-sided disease or prior valve intervention. The study will help clarify whether AF type and burden drive tricuspid remodeling even when significant TR is not present.

Why it matters

Who can join: the full rules

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

Where it's running

• Centro Cardiologico Monzino; IRCCS
  Milan, Milan, Italy Recruiting

Study contacts

• Principal investigator: Gianluca Pontone, MD — Centro Cardiologico Monzino, IRCCS

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.