Natural History of Atrial Fibrillation-Induced Tricuspid Valve Remodeling in the Absence of Significant Tricuspid Regurgitation: A Three-Dimensional Echocardiographic Study (TRICUSPID-AF)
| Registry | NCT07617974, acronym TRICUSPID-AF |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Enrollment | 66 (Estimated) |
| Sponsor | Centro Cardiologico Monzino (Other); collaborators: Istituto Clinico Humanitas |
| Conditions | Atrial Fibrillation (AF), Tricuspid Regurgitation (TR) |
| Dates | start 2026-05-04, primary completion 2027-05-31 (estimated), completion 2027-05-31 (estimated), first posted 2026-06-01, last updated 2026-06-01 |
| Locations | 1 site in Italy |
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All trials for Atrial Fibrillation (AF) All trials for Tricuspid Regurgitation (TR)
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 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. |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| Centro Cardiologico Monzino; IRCCS | Milan, Milan | Italy | Recruiting |