Centro Cardiologico Monzino; IRCCS
Milan, 20133, Italy
Location status: Recruiting
NCT Number: NCT07617974
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Milan, 20133, Italy
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Eligible for enrollment in the control group will be:
Exclusion criteria
Time frame: 12 months
Time frame: over 12 months
Time frame: 12 months
Time frame: 12 months
Time frame: 12 months
Time frame: 12 months
Centro Cardiologico Monzino
Other
Natural History of Atrial Fibrillation-Induced Tricuspid Valve Remodeling in the Absence of Significant Tricuspid Regurgitation: A Three-Dimensional Echocardiographic Study (TRICUSPID-AF)
Acronym: TRICUSPID-AF
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07607093
Arrhythmias, Cardiac, Atrial Fibrillation
Seoul, South Korea
View Trial DetailsNCT07085650
Arrhythmias, Cardiac, Atrial Fibrillation
Shenyang, Liaoning, China
View Trial DetailsNCT07298473
Arrhythmias, Cardiac, Atrial Fibrillation
Birmingham, Alabama, United States
View Trial DetailsNCT07738523
Arrhythmias, Cardiac, Atrial Fibrillation
Getafe, Madrid, Spain
View Trial Details