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NCT Number: NCT07607093

Efficacy of Early Rhythm Control in AF With TR Patients

Atrial fibrillation is frequently accompanied by tricuspid regurgitation and may contribute to right atrial and tricuspid annular remodeling, leading to progression of tricuspid regurgitation and adverse clinical outcomes. However, whether early rhythm control improves prognosis in patients with atrial fibrillation and tricuspid regurgitation remains unclear. This study will compare early rhythm control with usual care in these patients, using a composite outcome of cardiac death, heart failure admission, stroke, and tricuspid valve surgery.

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Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tricuspid Regurgitation (TR) Tricuspid Valve Insufficiency

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Medical Center

Seoul, 06351, South Korea

Location status: Recruiting

Location contact

Ju Youn Kim, Ph.D

CONTACT

[email protected]

82+ 2-3410-3419

About this study

Atrial fibrillation and tricuspid regurgitation frequently coexist in clinical practice. Atrial fibrillation may promote right atrial enlargement and tricuspid annular dilatation, which can aggravate functional tricuspid regurgitation over time. Conversely, significant tricuspid regurgitation may further increase right-sided volume overload, worsen atrial remodeling, and contribute to the persistence or progression of atrial fibrillation. This bidirectional relationship may lead to heart failure, thromboembolic events, and an increased need for tricuspid valve intervention.

Although early rhythm control has been shown to improve cardiovascular outcomes in selected patients with atrial fibrillation, its clinical benefit in patients with concomitant tricuspid regurgitation has not been well established. In particular, it remains uncertain whether maintaining sinus rhythm at an early stage can slow the progression of right-sided cardiac remodeling, reduce heart failure events, and improve long-term prognosis in this population.

This study is designed to evaluate the prognostic impact of early rhythm control compared with usual care in patients with atrial fibrillation and tricuspid regurgitation. The primary endpoint will be a composite of cardiac death, heart failure admission, stroke, and tricuspid valve surgery. By comparing these clinically meaningful outcomes between the two treatment strategies, this study aims to clarify whether early rhythm control should be considered as an active therapeutic approach in patients with atrial fibrillation complicated by tricuspid regurgitation.

The study will use retrospectively collected data from patients diagnosed with atrial fibrillation and tricuspid regurgitation between January 1, 2013 and December 31, 2023. Clinical outcomes will be assessed during this observation period.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with concomitant atrial fibrillation and tricuspid regurgitation.

Exclusion criteria

  • Patients with a history of valvular surgery
  • Patients with congenital heart disease
  • Patients with primary pulmonary hypertension
  • Patients with CIED implantation prior to the diagnosis of tricuspid regurgitation
  • Patients diagnosed with TR only after the initiation of rhythm control therapy for AF

Treatment and study plan

Anti-arrhythmic drugs for rhythm control

Drug

flecainide, propafenone, pilsicainide, sotalol, amiodarone, dronedarone

DC cardioversion, catheter ablation for rhythm control

Procedure

Direct-current cardioversion may be performed to acutely restore sinus rhythm, particularly in patients with persistent atrial fibrillation or symptomatic rhythm deterioration. Catheter ablation may be considered as a more definitive rhythm-control strategy to reduce atrial fibrillation burden and maintain sinus rhythm over the long term.

Usual Care

Other

General management without atrial fibrillation rhythm control treatment.(Observation without additional medication, or heart rate control treatment if necessary)

Primary outcomes

  1. A composite of cardiac death, hospitalization for heart failure, stroke, and tricuspid valve surgery

    Time frame: From January 1, 2013 to December 31, 2023

    The incidence rate of the major clinical events Major clinical event is;

    • Cardiac death Death attributable to cardiac causes, including heart failure, myocardial infarction, fatal arrhythmia, sudden cardiac death, or other cardiovascular causes.
    • Hospitalization for heart failure Hospital admission due to worsening signs or symptoms of heart failure requiring medical treatment, including intravenous diuretics, inotropes, vasodilators, or other heart failure-directed therapy.
    • Stroke A new neurological deficit of presumed vascular origin, including ischemic or hemorrhagic stroke, confirmed by clinical evaluation and/or brain imaging.
    • Tricuspid valve surgery Surgical or transcatheter intervention for tricuspid valve disease, including tricuspid valve repair or replacement.

Secondary outcomes

  1. All cause death

    Time frame: From January 1, 2013 to December 31, 2023

    The incidence rate of all-cause death during the observation period.

  2. Cardiac death

    Time frame: From January 1, 2013 to December 31, 2023

    The incidence rate of cardiac death during the observation period.

  3. Hospitalization for heart failure

    Time frame: From January 1, 2013 to December 31, 2023

    The incidence rate of hospitalization for heart failure during the observation period. (admission due to worsening signs or symptoms of heart failure requiring medical treatment, including intravenous diuretics, inotropes, vasodilators, or other heart failure-directed therapy)

  4. Stroke

    Time frame: From January 1, 2013 to December 31, 2023

    The incidence rate of stroke during the observation period. (new neurological deficit of presumed vascular origin, including ischemic or hemorrhagic stroke, confirmed by clinical evaluation and/or brain imaging)

  5. Tricuspid valve surgery

    Time frame: From January 1, 2013 to December 31, 2023

    The incidence rate of tricuspid valve surgery during the observation period. (surgical or transcatheter intervention for tricuspid valve disease, including tricuspid valve repair or replacement)

  6. Pacemaker implantation

    Time frame: From January 1, 2013 to December 31, 2023

    The incidence rate of pacemaker implantation during the observation period. (new implantation of a permanent pacemaker during the observation period, including single-chamber or dual-chamber pacemaker implantation, when performed for clinically indicated bradyarrhythmia or conduction disease)

Study contacts

Contact information is provided by the study sponsor or research team.

Ju Youn Kim, Ph.D

CONTACT

[email protected]

82+ 10-5482-7307

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Acronym: TRAF

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 26, 2026
Registry last updated
May 29, 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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