Bi-atrial Versus Left Atrial Ablation for Patients With Rheumatic Mitral Valve Disease and Non-paroxysmal Atrial Fibrillation

Persistent Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05021601
• Other study ID #: 2021-1515
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2022
• Est. completion date: July 2025

Study information

• Verified date: June 2024
• Source: China National Center for Cardiovascular Diseases
• Contact: Zhe Zheng, MD,PhD
• Phone: : +86-010-88396051
• Email: zhengzhe[@]fuwai.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: July 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent Atrial Fibrillation
• Rheumatic Diseases

Intervention

Procedure:
• Bi-atrial ablation
This intervention includes mitral valve surgery concomitant with left atrial ablation and right atrial ablation.
• Left atrial ablation
This intervention includes mitral valve surgery concomitant with left atrial ablation alone.

Locations

Country	Name	City	State
China	Fuwai Hospital	Beijing	Beijing
China	Nanjing First Hospital, Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At 12-month after intervention
Secondary	Survival rate without permanent pacemaker implantation (Key secondary outcome)	Percentage of participants who did not have a new permanent pacemaker implanted.	At 12-month after intervention
Secondary	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.	At 12-month after intervention
Secondary	Burden of atrial fibrillation	Burden of atrial fibrillation according to 3-day Holter monitoring.	At 12-month after intervention
Secondary	Major adverse events	Including cardiac death, stroke, heart failure requiring rehospitalization, embolic events or bleeding events requiring rehospitalization.	At 12-month after intervention
Secondary	Cardiac function	Documented by echocardiography (left ventricular ejection fraction).	At 12-month after intervention