Efficacy of Early Rhythm Control in AF With TR Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Anti-arrhythmic drugs for rhythm control, DC cardioversion, catheter ablation for rhythm control, Usual care.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation (AF), Tricuspid Regurgitation (TR). Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Interventions
- 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. - Other Usual care
General management without atrial fibrillation rhythm control treatment.(Observation without additional medication, or heart rate control treatment if necessary)
Primary outcome measures
- A composite of cardiac death, hospitalization for heart failure, stroke, and tricuspid valve surgery [Time frame: From January 1, 2013 to December 31, 2023]
Secondary outcome measures (6)
- All cause death [Time frame: From January 1, 2013 to December 31, 2023]
- Cardiac death [Time frame: From January 1, 2013 to December 31, 2023]
- Hospitalization for heart failure [Time frame: From January 1, 2013 to December 31, 2023]
- Stroke [Time frame: From January 1, 2013 to December 31, 2023]
- Tricuspid valve surgery [Time frame: From January 1, 2013 to December 31, 2023]
- Pacemaker implantation [Time frame: From January 1, 2013 to December 31, 2023]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- Samsung Medical Center — Seoul
Identifiers
NCT: NCT07607093 · SMC 2025-05-075-1