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

NCT07617974 | Recruiting

• 1 other identifier: L2-592
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation (AF); Tricuspid Regurgitation (TR)

Outcome Measures

Primary Outcomes (1)

• Mean 3D Tricuspid Annular Geometry Parameters Measured by 3D Echocardiography in Patients With Paroxysmal vs Persistent Atrial Fibrillation

  12 months

Secondary Outcomes (5)

• Change From Baseline in 3D Tricuspid Annular Geometry Parameters Measured by 3D Echocardiography

  over 12 months

• Number of Participants Developing ≥ Moderate Tricuspid Regurgitation Assessed by Echocardiography

  12 months

• Correlation Between Atrial Fibrillation Burden Assessed by Holter ECG and Change in 3D Tricuspid Annular Geometry (and Development of ≥ Moderate Tricuspid Regurgitation)

  12 months

• Association Between Baseline Echocardiographic Parameters and Development of ≥ Moderate Tricuspid Regurgitation

  12 months

• Correlation Between Changes in 3D Tricuspid and Mitral Annular Geometry Measured by 3D Echocardiography

  12 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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:
• all consecutive patients with structurally normal hearts and no history of AF or;
• moderate atrial functional tricuspid regurgitation and AF, in the absence of significant left-sided valvular disease or prior valvular surgery.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro Cardiologico Monzino: lead
• Istituto Clinico Humanitas: collaborator

Study Sites (1)

Centro Cardiologico Monzino; IRCCS

Milan, Milan, 20133, Italy

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Valve Diseases

Study Officials

• Gianluca Pontone, MD

  Centro Cardiologico Monzino, IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: June 1, 2026
• Study Start: May 4, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: June 1, 2026

Record last verified: 2026-05

Locations

IT (1)