NCT07617974 Natural History of Atrial Fibrillation-Induced Tricuspid Valve Remodeling in the Absence of Significant Tricuspid Regurgitation: A Three-Dimensional Echocardiographic Study
| NCT ID | NCT07617974 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centro Cardiologico Monzino |
| Condition | Atrial Fibrillation (AF) |
| Study Type | OBSERVATIONAL |
| Enrollment | 66 participants |
| Start Date | 2026-05-04 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 66 participants in total. It began in 2026-05-04 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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: 1. all consecutive patients with structurally normal hearts and no history of AF or; 2. 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
Contact & Investigator
Gianluca Pontone, MD
PRINCIPAL INVESTIGATOR
Centro Cardiologico Monzino, IRCCS
Frequently Asked Questions
Who can join the NCT07617974 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atrial Fibrillation (AF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07617974 currently recruiting?
Yes, NCT07617974 is actively recruiting participants. Visit ClinicalTrials.gov or contact Centro Cardiologico Monzino to inquire about joining.
Where is the NCT07617974 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT07617974 clinical trial?
NCT07617974 is sponsored by Centro Cardiologico Monzino. The principal investigator is Gianluca Pontone, MD at Centro Cardiologico Monzino, IRCCS. The trial plans to enroll 66 participants.
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