Efficacy of Early Rhythm Control in AF With TR Patients

Condition(s) studied

Investigational drug(s) / intervention(s)

Anti-arrhythmic drugs for rhythm control: flecainide, propafenone, pilsicainide, sotalol, amiodarone, dronedarone

DC 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.

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

Study 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

Primary outcome measure(s)

• A composite of cardiac death, hospitalization for heart failure, stroke, and tricuspid valve surgery — From January 1, 2013 to December 31, 2023
  The incidence rate of the major clinical events Major clinical event is; 1. Cardiac death Death attributable to cardiac causes, including heart failure, myocardial infarction, fatal arrhythmia, sudden cardiac death, or other cardiovascular causes. 2. 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. 3. Stroke A new neurological deficit of presumed vascular origin, including ischemic or hemorrhagic stroke, confirmed by clinical evaluation and/or brain imaging. 4. Tricuspid valve surgery Surgical or transcatheter intervention for tricuspid valve disease, including tricuspid valve repair or replacement.

Trial sites (1)

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