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NCT Number: NCT07617974

Natural History of Atrial Fibrillation-Induced Tricuspid Valve Remodeling in the Absence of Significant Tricuspid Regurgitation: A Three-Dimensional Echocardiographic Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centro Cardiologico Monzino; IRCCS

Milan, 20133, Italy

Location status: Recruiting

Location contact

Chiara Centenaro

CONTACT

[email protected]

0258002031

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Mean 3D Tricuspid Annular Geometry Parameters Measured by 3D Echocardiography in Patients With Paroxysmal vs Persistent Atrial Fibrillation

    Time frame: 12 months

Secondary outcomes

  1. Change From Baseline in 3D Tricuspid Annular Geometry Parameters Measured by 3D Echocardiography

    Time frame: over 12 months

  2. Number of Participants Developing ≥ Moderate Tricuspid Regurgitation Assessed by Echocardiography

    Time frame: 12 months

  3. 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

  4. Association Between Baseline Echocardiographic Parameters and Development of ≥ Moderate Tricuspid Regurgitation

    Time frame: 12 months

  5. Correlation Between Changes in 3D Tricuspid and Mitral Annular Geometry Measured by 3D Echocardiography

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Centro Cardiologico Monzino

Other

Collaborators

  • Istituto Clinico Humanitas

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 1, 2026
Registry last updated
Jun 1, 2026

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.

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