Clinical trial NCT05021601: Bi-atrial Versus Left Atrial Ablation for Patients With Rheumatic Mitral Valve Disease and Non-paroxysmal Atrial Fibrillation
Official title: Bi-atrial Versus Left Atrial Ablation for Patients With Rheumatic Mitral Valve Disease and Non-paroxysmal Atrial Fibrillation: a Multicenter, Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Persistent Atrial Fibrillation
Keywords: Rheumatic mitral valve disease
Surgical ablation
Mitral valve surgery
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2021-08-25
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Survival rate without any recurrence of atrial tachyarrhythmias in the absence of antiarrhythmic drugs
timeFrame: At 12-month after intervention
Secondary outcomes:
measure: Survival rate without permanent pacemaker implantation (Key secondary outcome)
timeFrame: At 12-month after intervention
measure: Survival rate without any recurrence of atrial tachyarrhythmias with antiarrhythmic drugs
timeFrame: At 12-month after intervention
measure: Burden of atrial fibrillation
timeFrame: At 12-month after intervention
measure: Major adverse events
timeFrame: At 12-month after intervention
measure: Cardiac function
timeFrame: At 12-month after intervention
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital
state: Beijing
city: Nanjing
country: China
facility: Nanjing First Hospital, Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Zhe Zheng, MD,PhD
role: STUDY_CHAIR
References: