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| Name | Class |
|---|---|
| Istituto Clinico Humanitas | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
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| Measure | Description | Time Frame |
|---|---|---|
| Mean 3D Tricuspid Annular Geometry Parameters Measured by 3D Echocardiography in Patients With Paroxysmal vs Persistent Atrial Fibrillation | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Eligible for enrollment in the control group will be:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Gianluca Pontone, MD | Centro Cardiologico Monzino, IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Cardiologico Monzino; IRCCS | Recruiting | Milan | Milan | 20133 | Italy |
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| 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 |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D014262 | Tricuspid Valve Insufficiency |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006349 | Heart Valve Diseases |
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