RecruitingNCT07607093

Efficacy of Early Rhythm Control in AF With TR Patients


Sponsor

Samsung Medical Center

Enrollment

5,800 participants

Start Date

Feb 18, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Inclusion Criteria1

  • Patients with concomitant atrial fibrillation and tricuspid regurgitation.

Exclusion Criteria5

  • 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

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Interventions

DRUGAnti-arrhythmic drugs for rhythm control

flecainide, propafenone, pilsicainide, sotalol, amiodarone, dronedarone

PROCEDUREDC cardioversion, catheter ablation for rhythm control

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.

OTHERUsual care

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


Locations(1)

Samsung Medical Center

Seoul, Seoul, South Korea

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NCT07607093


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