Efficacy of Early Rhythm Control in AF With TR Patients (TRAF)

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation (AF); Tricuspid Regurgitation (TR)
• Intervention / Treatment: Drug: Anti-arrhythmic drugs for rhythm control; Procedure: DC cardioversion, catheter ablation for rhythm control; Other: Usual care

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 5800

Contacts and Locations

• Study Contact: Name: Ju Youn Kim, Ph.D; Phone Number: 82+ 10-5482-7307; Email: kzzoo921@gmail.com

Study Locations

• South Korea
  • Seoul
    • Seoul, Seoul, South Korea, 06351
      • Recruiting
      • Samsung Medical Center
      • Contact: Ju Youn Kim, Ph.D; Phone Number: 82+ 2-3410-3419; Email: kzzoo921@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The investigator emulated a sequential target trial comparing early rhythm control with usual care among patients with atrial fibrillation and tricuspid regurgitation, using data from the Korean National Health Insurance Service (K-NHIS) claims database.

The K-NHIS database represents the entire population of Korea. The K-NHIS database covers the total population of Korea. The NHIS database includes information on all individuals in Korea, such as demographics, diagnosis codes based on the International Classification of Diseases, 10th Revision (ICD-10), procedures, prescriptions (coded by ATC codes), utilization of healthcare services, and mortality linked to national statistics. The investigator further linked these data with the National Health Screening Program, which provides biennial standardized health examination results, including laboratory measurements such as serum creatinine and hemoglobin, using anonymized individual identifiers.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
early rhythm control group; Patients who received rhythm control therapy(include catheter ablation, cardioversion, anti-arrhythmic drugs) within 2 years of new-onset atrial fibrillation	Drug: Anti-arrhythmic drugs for rhythm control; flecainide, propafenone, pilsicainide, sotalol, amiodarone, dronedarone; Procedure: 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 group; Patients who received usual care include rate control therapy without early rhythm control intervention within 2 years of new-onset atrial fibrillation	Other: Usual care; General management without atrial fibrillation rhythm control treatment.(Observation without additional medication, or heart rate control treatment if necessary)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A composite of cardiac death, hospitalization for heart failure, stroke, and tricuspid valve surgery	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.	From January 1, 2013 to December 31, 2023

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All cause death	The incidence rate of all-cause death during the observation period.	From January 1, 2013 to December 31, 2023
Cardiac death	The incidence rate of cardiac death during the observation period.	From January 1, 2013 to December 31, 2023
Hospitalization for heart failure	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)	From January 1, 2013 to December 31, 2023
Stroke	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)	From January 1, 2013 to December 31, 2023
Tricuspid valve surgery	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)	From January 1, 2013 to December 31, 2023
Pacemaker implantation	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)	From January 1, 2013 to December 31, 2023

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: May 19, 2026
• First Submitted That Met QC Criteria: May 19, 2026
• First Posted (Actual): May 26, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: early rhythm control
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Heart Valve Diseases; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation; Tricuspid Valve Insufficiency; Therapeutics; Surgical Procedures, Operative; Ablation Techniques; Radiofrequency Ablation; Radiofrequency Therapy; Catheter Ablation
• Other Study ID Numbers: SMC 2025-05-075-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared because this study uses de-identified claims data from the Korean National Health Insurance Service (K-NHIS) database. The investigators are not permitted to provide or redistribute participant-level data under K-NHIS data use policies and privacy regulations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No