Effect of Intensive Rhythm Control Strategy in Patients With Atrial Fibrillation and Secondary Mitral or Tricuspid Regurgitation: A Randomized Controlled Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0011826

Enrollment

500

Registered

2026-04-09

Start date

2026-05-04

Completion date

Unknown

Last updated

2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : Patients assigned to the conventional strategy group will not undergo intensive interventions specifically aimed at sinus rhythm conversion. Instead, they will receive standard ca

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adults aged 18 to under 90 years 2. Patients diagnosed with atrial fibrillation 3. Patients with moderate or greater mitral or tricuspid regurgitation confirmed by transthoracic echocardiography within the past 3 months

Exclusion criteria

Exclusion criteria: 1. Inability to attempt intensive rhythm control, or rhythm control is deemed futile due to permanent atrial fibrillation 2. Patients maintaining sinus rhythm on anti-arrhythmic drugs prior to enrollment, or those with a history of catheter ablation or the Maze procedure 3. Confirmed primary mitral or tricuspid valve disease 4. Previous history of surgical or transcatheter intervention on the mitral or tricuspid valve 5. Confirmed Cardiac Implantable Electronic Device (CIED) related TR 6. Life expectancy of less than one year 7. Pregnant or lactating women

Design outcomes

Primary

Measure	Time frame
Change in effective regurgitant orifice area from baseline to 1 year follow-up);A composite of cardiac death, stroke, hospitalization due to heart failure, or mitral/tricuspid valve intervention 2 years follow-up	—

Secondary

Measure	Time frame
mitral/tricuspid valve intervention;All-cause mortality;cardiac mortality;hospitalization due to heart failure;hospitalization due to any cause;IV furosemide infusion;diuretics dose;improvement in mitral or tricuspid regurgitation;NTproBNP;functional status;AFEQT score;echocardiographic parameters;AF recurrence and burden in ECG and 3-day Holter;safety outcomes	—

Countries

Korea, Republic of

Contacts

Public ContactJihoon Kim

Samsung Medical Center

novolley@naver.com+82-2-3410-3419

Outcome results