Natural History of Atrial Fibrillation-Induced Tricuspid Valve Remodeling in the Absence of Significant Tricuspid Regurgitation: A Three-Dimensional Echocardiographic Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation (AF), Tricuspid Regurgitation (TR). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Natural History of Atrial Fibrillation-Induced Tricuspid Valve Remodeling in the Absence of Significant Tricuspid Regurgitation: A Three-Dimensional Echocardiographic Study (TRICUSPID-AF)
Overview
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.
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.
Primary outcome measures
- Mean 3D Tricuspid Annular Geometry Parameters Measured by 3D Echocardiography in Patients With Paroxysmal vs Persistent Atrial Fibrillation [Time frame: 12 months]
Secondary outcome measures (5)
- Change From Baseline in 3D Tricuspid Annular Geometry Parameters Measured by 3D Echocardiography [Time frame: over 12 months]
- Number of Participants Developing ≥ Moderate Tricuspid Regurgitation Assessed by Echocardiography [Time frame: 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]
- Association Between Baseline Echocardiographic Parameters and Development of ≥ Moderate Tricuspid Regurgitation [Time frame: 12 months]
- Correlation Between Changes in 3D Tricuspid and Mitral Annular Geometry Measured by 3D Echocardiography [Time frame: 12 months]
Eligibility criteria
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:
- 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.
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Centro Cardiologico Monzino; IRCCS — Milan
Identifiers
NCT: NCT07617974 · L2-592