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Clinical Trials/NCT07607093
NCT07607093RecruitingNot Applicable

Efficacy of Early Rhythm Control in AF With TR Patients

Samsung Medical Center1 site in 1 country5,800 target enrollmentStarted: February 18, 2026Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
5,800
Locations
1

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Sex
All
Accepts 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

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ju Youn Kim

MD, PhD

Samsung Medical Center

Study Sites (1)

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