Atrial Fibrillation (AF)TRAFNCT07607093
Efficacy of Early Rhythm Control in AF With TR Patients
An observational study of Atrial Fibrillation (AF) and Tricuspid Regurgitation (TR), run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation (AF), Tricuspid Regurgitation (TR)
- Type of treatment
- Surgery or procedure
- How many people
- 5,800 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Feb 2026to 28 Feb 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients with concomitant atrial fibrillation and tricuspid regurgitation.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, Seoul, 06351
Ju Youn Kim, Ph.D, 82+ 2-3410-3419, kzzoo921@gmail.com
About this study
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.
Read the 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.
- Being tested
- Anti-arrhythmic drugs for rhythm control, DC cardioversion, catheter ablation for rhythm control, Usual care
- Keywords
- early rhythm control
- Medical subject headings
- Atrial Fibrillation, Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-arrhythmic drugs for rhythm controlDrug
flecainide, propafenone, pilsicainide, sotalol, amiodarone, dronedarone
DC cardioversion, catheter ablation for rhythm controlProcedure or surgery
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 careOther
General management without atrial fibrillation rhythm control treatment.(Observation without additional medication, or heart rate control treatment if necessary)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Anti-arrhythmic drugs for rhythm control; Procedure: DC cardioversion, catheter ablation for rhythm control | |
| 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 Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From January 1, 2013 to December 31, 2023
Secondary outcomes (6)
All cause death
The incidence rate of all-cause death during the observation period.
Measured: From January 1, 2013 to December 31, 2023
Cardiac death
The incidence rate of cardiac death during the observation period.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: From January 1, 2013 to December 31, 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start18 Feb 2026
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ju Youn Kim, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07607093
- Sponsor's protocol ID
- SMC 2025-05-075-1
- Acronym
- TRAF
- Status last verified
- May 2026
- First submitted
- 19 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.