Actively Recruiting
Natural History of Atrial Fibrillation-Induced Tricuspid Valve Remodeling in the Absence of Significant Tricuspid Regurgitation A Three-Dimensional Echocardiographic Study (TRICUSPID-AF)
Led by Centro Cardiologico Monzino · Updated on 2026-06-01
66
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Centro Cardiologico Monzino
Lead Sponsor
I
Istituto Clinico Humanitas
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to understand how the tricuspid valve changes in patients with atrial fibrillation (AF) who do not have significant tricuspid regurgitation (TR). The study focuses on patients with paroxysmal or persistent AF and looks at how the burden of AF affects tricuspid valve remodeling over time. Results will be compared to control groups including people without AF and those with moderate atrial functional TR and AF but no significant left-sided valve disease or previous valve surgery. Participants with paroxysmal or persistent AF who are scheduled for transthoracic echocardiography (TTE) before AF ablation will be enrolled. They will have 3D imaging of the tricuspid valve and undergo repeat TTE one year later. The study uses an AI-powered 3D tool to analyze the tricuspid valve geometry. AF burden will be monitored through Holter ECG at baseline, 3 months, and 12 months. The study includes control groups with normal hearts or with moderate atrial functional TR and AF. During the study, participants will have TTE scans to measure tricuspid annular geometry and strain analysis of right heart chambers. Holter ECG will track the AF burden. The primary outcome is the difference in 3D tricuspid annular geometry between paroxysmal and persistent AF after 12 months. Secondary outcomes include changes in valve geometry, development of moderate or worse TR, and the relationship between AF burden and valve remodeling. The study will follow participants for at least one year without additional interventions.
CONDITIONS
Brief Title
Natural History of Atrial Fibrillation-Induced Tricuspid Valve Remodeling in the Absence of Significant Tricuspid Regurgitation: A Three-Dimensional Echocardiographic Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Patients with paroxysmal or persistent atrial fibrillation undergoing transthoracic echocardiography prior to AF ablation with 3D tricuspid valve imaging
- Control group includes patients with structurally normal hearts and no history of AF
- Control group includes patients with moderate atrial functional tricuspid regurgitation and AF without significant left-sided valve disease or prior valve surgery
You will not qualify if you...
- Moderate or greater tricuspid regurgitation by multiparametric assessment
- Presence of arrhythmias other than atrial fibrillation
- Previous atrial fibrillation ablation procedures
- Rapid ventricular response (heart rate over 110 bpm) during baseline echocardiography
- Inadequate image quality for analysis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for initial echocardiography and assessment
Duration - Baseline assessments prior to AF ablation
Participants undergo transthoracic echocardiography including 3D tricuspid valve imaging and Holter ECG monitoring to assess atrial fibrillation burden and valve geometry.
1 visit (in-person) for echocardiography and Holter ECG monitoring; additional Holter ECG monitoring at 3 months
Duration - 12 months
Participants are monitored over 12 months with repeat echocardiography and Holter ECG to evaluate changes in tricuspid valve geometry and atrial fibrillation burden.
1 follow-up visit at 12 months for repeat echocardiography and Holter ECG monitoring; Holter ECG monitoring also at 3 months
Trial Site Locations
Total: 1 location
1
Centro Cardiologico Monzino; IRCCS
Milan, Milan, Italy, 20133
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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