Persistent Atrial Fibrillation
Conditions
Keywords
Rheumatic mitral valve disease, Surgical ablation, Mitral valve surgery
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREBi-atrial ablation
This intervention includes mitral valve surgery concomitant with left atrial ablation and right atrial ablation.
PROCEDURELeft atrial ablation
This intervention includes mitral valve surgery concomitant with left atrial ablation alone.
Sponsors
China National Center for Cardiovascular Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Diagnosis of persistent atrial fibrillation(AF) or long-standing persistent AF by medical history and Holter monitoring (persistent AF lasting more than 7 days; long-standing persistent AF lasting more than 1 year). * Rheumatic mitral valve disease(RMVD) requires mitral valve surgery( RMVD was determined by history of acute rheumatic fever, valve morphology, echocardiographic findings and pathological diagnosis). * Consent to surgical ablation of AF
Exclusion criteria
* Paroxysmal AF * Degenerative or ischemic mitral valve disease * Evidence of active infection * Previous catheter ablation or surgical ablation for AF * Surgical management of hypertrophic obstructive cardiomyopathy * Absolute contraindications for anticoagulation therapy * Left atrial thrombosis (not including left atrial appendage thrombosis alone) * Chronic obstructive pulmonary disease(Forced expiratory volume in 1 second (FEV1)\<30% anticipated value) * Uncontrolled hypo- or hyperthyroidism * Mental impairment or other conditions that may not allow participants to understand the nature, significance, and scope of study * Left atrial diameter\>70mm * Right ventricular dysfunction (TAPSE\<16) or moderate to severe tricuspid regurgitation or pulmonary artery pressure (estimated by echocardiography) \>60mmHg * Coronary artery bypass grafting is required for participants with coronary heart disease * Previous cardiac surgery * Refuse to participate in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival rate without any recurrence of atrial tachyarrhythmias in the absence of antiarrhythmic drugs | At 12-month after intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival rate without permanent pacemaker implantation (Key secondary outcome) | At 12-month after intervention | Percentage of participants who did not have a new permanent pacemaker implanted. |
| Survival rate without any recurrence of atrial tachyarrhythmias with antiarrhythmic drugs | At 12-month after intervention | 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. |
| Burden of atrial fibrillation | At 12-month after intervention | Burden of atrial fibrillation according to 3-day Holter monitoring. |
| Major adverse events | At 12-month after intervention | Including cardiac death, stroke, heart failure requiring rehospitalization, embolic events or bleeding events requiring rehospitalization. |
| Cardiac function | At 12-month after intervention | Documented by echocardiography (left ventricular ejection fraction). |
Countries
China
Contacts
Primary ContactZhe Zheng, MD,PhD
Backup ContactChunyu Yu, MD
Outcome results
None listed