Natural History of Atrial Fibrillation-Induced Tricuspid Valve Remodeling in the Absence of Significant Tricuspid Regurgitation: A Three-Dimensional Echocardiographic Study (TRICUSPID-AF)

May 26, 2026 updated by: Centro Cardiologico Monzino

Natural History of Atrial Fibrillation-Induced Tricuspid Valve Remodeling in the Absence of Significant Tricuspid Regurgitation: A Three-Dimensional Echocardiographic Study (TRICUSPID-AF)

This is a prospective, observational, multicenter study aimed at characterizing tricuspid valve remodeling in patients with atrial fibrillation (AF) without significant tricuspid regurgitation (TR), in relation to AF burden progression.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Patients with paroxysmal or persistent AF undergoing transthoracic echocardiography (TTE) prior to AF ablation will be enrolled and will undergo repeat TTE at 1-year follow-up. The echocardiographic assessment will include standard measurements, right atrial and right ventricular strain analysis, and 3D acquisitions of the tricuspid valve (and mitral valve, if feasible). Tricuspid valve geometry will be analyzed using an AI-powered 3D quantification tool. AF burden will be assessed through serial Holter ECG monitoring at baseline, 3, and 12 months.

The primary endpoint is the difference in 3D tricuspid annular geometry between patients with paroxysmal and persistent AF. Secondary endpoints include interval changes in tricuspid annular geometry over one year, development of ≥ moderate TR, association between AF burden and tricuspid remodeling, identification of echocardiographic predictors of TR progression, and correlation between tricuspid and mitral valve changes.

Study results will be compared with two control groups: (1) subjects without AF and structurally normal hearts, and (2) patients with ≥ moderate atrial functional TR and AF, without significant left-sided valvular disease or prior valve interventions.

Study Type

Observational

Enrollment (Estimated)

66

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Prospective Cohort
Participants with paroxysmal or persistent atrial fibrillation undergoing clinically indicated transthoracic echocardiography (TTE) prior to catheter ablation with acquisition of a three-dimensional (3D) tricuspid valve dataset. Participants will undergo repeat transthoracic echocardiography at 12-month follow-up and rhythm monitoring with Holter ECG according to standard clinical practice. No study-specific interventions are planned.
Control group

The study cohort will be compared with control populations undergoing clinically indicated transthoracic echocardiography:

  1. subjects with structurally normal hearts and no history of atrial fibrillation;
  2. patients with atrial fibrillation and ≥ moderate atrial functional tricuspid regurgitation, in the absence of significant left-sided valvular disease or prior valvular surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean 3D Tricuspid Annular Geometry Parameters Measured by 3D Echocardiography in Patients With Paroxysmal vs Persistent Atrial Fibrillation
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in 3D Tricuspid Annular Geometry Parameters Measured by 3D Echocardiography
Time Frame: over 12 months
over 12 months
Number of Participants Developing ≥ Moderate Tricuspid Regurgitation Assessed by Echocardiography
Time Frame: 12 months
12 months
Correlation Between Atrial Fibrillation Burden Assessed by Holter ECG and Change in 3D Tricuspid Annular Geometry (and Development of ≥ Moderate Tricuspid Regurgitation)
Time Frame: 12 months
12 months
Association Between Baseline Echocardiographic Parameters and Development of ≥ Moderate Tricuspid Regurgitation
Time Frame: 12 months
12 months
Correlation Between Changes in 3D Tricuspid and Mitral Annular Geometry Measured by 3D Echocardiography
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Cardiologico Monzino

Collaborators

Istituto Clinico Humanitas

Investigators

  • Principal Investigator: Gianluca Pontone, MD, Centro Cardiologico Monzino, IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2026

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

May 8, 2026

First Submitted That Met QC Criteria

May 26, 2026

First Posted (Actual)

June 1, 2026

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L2-592

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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