Natural History of Atrial Fibrillation-Induced Tricuspid Valve Remodeling in the Absence of Significant Tricuspid Regurgitation: A Three-Dimensional Echocardiographic Study
Recruiting · NCT07617974 · Observational (researchers observe without assigning treatment) · Lead sponsor: Centro Cardiologico Monzino
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed.
- Centro Cardiologico Monzino; IRCCS - Milan, Milan, Italy