About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Consecutive patients with atrial fibrillation (paroxysmal or persistent) undergoing transthoracic echocardiography (TTE) prior to AF ablation with acquisition of a 3D TV dataset.
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.
Disqualifiers
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;
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Mean 3D Tricuspid Annular Geometry Parameters Measured by 3D Echocardiography in Patients With Paroxysmal vs Persistent Atrial Fibrillation
Secondary outcomes
Change From Baseline in 3D Tricuspid Annular Geometry Parameters Measured by 3D Echocardiography
Number of Participants Developing ≥ Moderate Tricuspid Regurgitation Assessed by Echocardiography
Correlation Between Atrial Fibrillation Burden Assessed by Holter ECG and Change in 3D Tricuspid Annular Geometry (and Development of ≥ Moderate Tricuspid Regurgitation)
Association Between Baseline Echocardiographic Parameters and Development of ≥ Moderate Tricuspid Regurgitation
Sponsors and contacts
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Centro Cardiologico Monzino
Lead sponsor
Istituto Clinico Humanitas
Collaborator