Atrial Fibrillation (AF), Tricuspid Regurgitation (TR)
Conditions
Keywords
early rhythm control
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.
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
DRUGAnti-arrhythmic drugs for rhythm control
flecainide, propafenone, pilsicainide, sotalol, amiodarone, dronedarone
PROCEDUREDC 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.
OTHERUsual care
General management without atrial fibrillation rhythm control treatment.(Observation without additional medication, or heart rate control treatment if necessary)
Sponsors
Samsung Medical Center
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All cause death | From January 1, 2013 to December 31, 2023 | The incidence rate of all-cause death during the observation period. |
| Cardiac death | From January 1, 2013 to December 31, 2023 | The incidence rate of cardiac death during the observation period. |
| Hospitalization for heart failure | From January 1, 2013 to December 31, 2023 | 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) |
| Stroke | From January 1, 2013 to December 31, 2023 | 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) |
| Tricuspid valve surgery | From January 1, 2013 to December 31, 2023 | 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) |
| Pacemaker implantation | From January 1, 2013 to December 31, 2023 | 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) |
Countries
South Korea
Contacts
CONTACTJu Youn Kim, Ph.D
Outcome results
None listed