Efficacy of Early Rhythm Control in AF With TR Patients
TRAF
1 other identifier
observational
5,800
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 18, 2026
CompletedFirst Submitted
Initial submission to the registry
May 19, 2026
CompletedFirst Posted
Study publicly available on registry
May 26, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2027
May 29, 2026
May 1, 2026
1 year
May 19, 2026
May 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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; 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.
From January 1, 2013 to December 31, 2023
Secondary Outcomes (6)
All cause death
From January 1, 2013 to December 31, 2023
Cardiac death
From January 1, 2013 to December 31, 2023
Hospitalization for heart failure
From January 1, 2013 to December 31, 2023
Stroke
From January 1, 2013 to December 31, 2023
Tricuspid valve surgery
From January 1, 2013 to December 31, 2023
- +1 more secondary outcomes
Study Arms (2)
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
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
Interventions
flecainide, propafenone, pilsicainide, sotalol, amiodarone, dronedarone
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.
General management without atrial fibrillation rhythm control treatment.(Observation without additional medication, or heart rate control treatment if necessary)
Eligibility Criteria
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.
You may qualify if:
- Patients with concomitant atrial fibrillation and tricuspid regurgitation.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, Seoul, 06351, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
May 19, 2026
First Posted
May 26, 2026
Study Start
February 18, 2026
Primary Completion (Estimated)
February 28, 2027
Study Completion (Estimated)
February 28, 2027
Last Updated
May 29, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share
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.