An interventional study of Bi-atrial ablation and Left atrial ablation in Persistent Atrial Fibrillation, sponsored by China National Center for Cardiovascular Diseases. Recruiting at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-13.
Sponsored by China National Center for Cardiovascular Diseases · Not applicable, Interventional, and Treatment
This study is aimed to compare the efficacy of bi-atrial ablation with left atrial ablation for atrial fibrillation during mitral valve surgery in patients with rheumatic mitral valve disease.
Atrial fibrillation (AF) is present in 40%-60% of patients with rheumatic mitral valve disease (RMVD), which is an independent predictor of mortality and late stroke. During mitral valve (MV) surgery, the open left atrium facilitates a bi-atrial ablation procedure. However, a simplified lesion set including isolated pulmonary vein isolation or posterior left atrial (LA) wall isolation or LA maze was usually applied. The current literatures provide insufficient evidence to determine the potential benefits of bi-atrial ablation procedure when comparing with LA ablation procrdure in patients with non-paroxysmal AF and RMVD.
Patients with RMVD often have longer history, which tends to affect the right atrium, including pulmonary hypertension or tricuspid regurgitation.The necessity of bi-atrial ablation procedure targeting the bi-atrial substrate for AF in RMVD requires to be explored. In this study, we aimed to compare the efficacy of bi-atrial ablation with LA ablation for AF during MV surgery in patients with RMVD.
377 studies on the registry are indexed under Rheumatic Diseases; 79 are open to participants now.
This study's planned enrollment of 320 is above the median of 74 across 210 interventional studies indexed under Rheumatic Diseases.
Browse Rheumatic Diseases studies →China National Center for Cardiovascular Diseases is the lead sponsor of 256 studies on the registry; 134 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants in this group will receive mitral valve surgery concomitant with bi-atrial ablation procedure.
Procedure: Bi-atrial ablation
Participants in this group will receive mitral valve surgery concomitant with left atrial ablation procedure.
Procedure: Left atrial ablation
This intervention includes mitral valve surgery concomitant with left atrial ablation and right atrial ablation.
This intervention includes mitral valve surgery concomitant with left atrial ablation alone.
Survival rate without any recurrence of atrial tachyarrhythmias in the absence of antiarrhythmic drugs
Without detections of atrial fibrillation, atrial flutter, or other atrial tachyarrhythmias with a duration of greater than 30 seconds documented by 3-day Holter monitoring in the absence of antiarrhythmic drugs.
Time frame: At 12-month after intervention
Survival rate without permanent pacemaker implantation (Key secondary outcome)
Percentage of participants who did not have a new permanent pacemaker implanted.
Time frame: At 12-month after intervention
Survival rate without any recurrence of atrial tachyarrhythmias with antiarrhythmic drugs
Without detections of atrial fibrillation, atrial flutter, or other atrial tachyarrhythmias with a duration of greater than 30 seconds documented by 3-day Holter monitoring with antiarrhythmic drugs.
Time frame: At 12-month after intervention
Burden of atrial fibrillation
Burden of atrial fibrillation according to 3-day Holter monitoring.
Time frame: At 12-month after intervention
Major adverse events
Including cardiac death, stroke, heart failure requiring rehospitalization, embolic events or bleeding events requiring rehospitalization.
Time frame: At 12-month after intervention
Cardiac function
Documented by echocardiography (left ventricular ejection fraction).
Time frame: At 12-month after intervention
Plan to share: No
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China National Center for Cardiovascular Diseases