An observational study in Atrial Fibrillation (AF) and Tricuspid Regurgitation (TR), sponsored by Centro Cardiologico Monzino. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-01.
Sponsored by Centro Cardiologico Monzino · Observational
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Among 252 studies in Atrial Fibrillation with a site in Italy — 44 open to participants now, 64 under way, 2 of them phase 3. Atrial Fibrillation · Italy.
Among the 252 studies in Atrial Fibrillation with a site in Italy, this one is the 84th largest by planned enrollment of the 95 observational ones that give a count, is one of 10 that started in 2026, is one of 95 observational ones, reaches primary completion later than 37 of the 63 other live ones, and was the 247th registered.
4,009 studies on the registry are indexed under Atrial Fibrillation; 960 are open to participants now.
Browse Atrial Fibrillation studies →44 of the 252 studies in Atrial Fibrillation with a site in Italy are open now. Recruiting first, the newest first:
Hospital Universitari Vall d'Hebron Research Institute · Sites in Italy, Belgium, Germany and 3 more countries
Ages 18+
Bayer · Sites in Italy, United States, Belgium and 5 more countries
Ages 18–85
Mitera Hospital · Sites in Italy, Croatia, Czechia and 5 more countries
Ages 18+
Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Sites in Italy
Ages 18+
Boston Scientific Corporation · Sites in Italy, Belgium, Croatia and 2 more countries
Ages 18+
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 611 Atrial Fibrillation studies recruiting now, 407 (67%) set no upper age limit and 43 (7%) stop at 75 or younger; 21 take children under 18; 43 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
252 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 13 · Phase 3 44 · Phase 4 20
First in 2000; this study’s year is marked. 10 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 66 is below the median of 300 across 1,400 observational studies indexed under Atrial Fibrillation.
Median enrollment 321 across the 156 interventional studies, 411 across the 95 observational. Of the 154 that completed or were terminated, 72 (47%) have results posted.
This tab as a report to print or save as PDF → With an account.
129 of 252 have an industry lead sponsor. The 10 most frequent:
Centro Cardiologico Monzino is the lead sponsor of 72 studies on the registry; 26 are open to participants now.
Centro Cardiologico Monzino has 5 studies filed under Atrial Fibrillation — fewer than ten, so there is no comparison to draw.
22 of the studies in Atrial Fibrillation with a site in Italy that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05757869Phase 3Janssen Research & Development, LLCA Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation | 2026-12-08 |
| NCT07901699Società Italiana di Medicina InternaResumption of Anticoagulation After Major Gastrointestinal Bleeding in Patients With Atrial Fibrillation | 2026-11 |
| NCT05005949Medtronic Cardiac Ablation SolutionsSTOP Persistent AF PAS | 2026-12 |
| NCT07429214Biosense Webster, Inc.A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF | 2026-12-30 |
| NCT07428564Biosense Webster, Inc.A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE PRO Software in Participants With PsAF | 2026-12-30 |
Add all 22 to your calendar (.ics) → With an account.
Among the 252 studies in Atrial Fibrillation with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
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.
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Eligible for enrollment in the control group will be:
Exclusion Criteria:
Participants with paroxysmal or persistent atrial fibrillation undergoing clinically indicated transthoracic echocardiography (TTE) prior to catheter ablation with acquisition of a three-dimensional (3D) tricuspid valve dataset. Participants will undergo repeat transthoracic echocardiography at 12-month follow-up and rhythm monitoring with Holter ECG according to standard clinical practice. No study-specific interventions are planned.
The study cohort will be compared with control populations undergoing clinically indicated transthoracic echocardiography: 1. subjects with structurally normal hearts and no history of atrial fibrillation; 2. patients with atrial fibrillation and ≥ moderate atrial functional tricuspid regurgitation, in the absence of significant left-sided valvular disease or prior valvular surgery.
Mean 3D Tricuspid Annular Geometry Parameters Measured by 3D Echocardiography in Patients With Paroxysmal vs Persistent Atrial Fibrillation
Time frame: 12 months
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
Started May 2026 (actual). Primary completion is estimated for May 2027, 12 months after the start.
Of 550 non-industry observational studies under Atrial Fibrillation, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 91. This study's planned 12 months is below that.
Counting every sponsor, half of 698 studies reached it within 38 months; a quarter within 22 and three quarters within 76.
How these figures are worked out, and which studies are left out of them.
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Centro Cardiologico Monzino