Efficacy of Early Rhythm Control in AF With TR Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorSamsung Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with concomitant atrial fibrillation and tricuspid regurgitation.
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Anti-arrhythmic drugs for rhythm control
Drugflecainide, propafenone, pilsicainide, sotalol, amiodarone, dronedarone
DC cardioversion, catheter ablation for rhythm control
Procedure/SurgeryDirect-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 care
Other interventionGeneral management without atrial fibrillation rhythm control treatment.(Observation without additional medication, or heart rate control treatment if necessary)
Treatment groups
5,800 Participants
are divided into 2 treatment groupsGroup A: early rhythm control group2 interventions
Group B: Usual care group1 intervention
Trial outcomes
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.
Time frame
From January 1, 2013 to December 31, 2023Secondary outcomes
1
All cause death
The incidence rate of all-cause death during the observation period.
Time frame
From January 1, 2013 to December 31, 20232
Cardiac death
The incidence rate of cardiac death during the observation period.
Time frame
From January 1, 2013 to December 31, 20233
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)
Time frame
From January 1, 2013 to December 31, 20234
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)
Time frame
From January 1, 2013 to December 31, 2023Sponsors and contacts
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Source ClinicalTrials.gov