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

Bi-atrial Versus Left Atrial Ablation for Patients With Rheumatic Mitral Valve Disease and Non-paroxysmal Atrial Fibrillation: a Multicenter, Prospective, Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Persistent Atrial Fibrillation
• Intervention / Treatment: Procedure: Bi-atrial ablation; Procedure: Left atrial ablation

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.

• Study Type: Interventional
• Enrollment (Estimated): 320
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhe Zheng, MD,PhD; Phone Number: : +86-010-88396051; Email: zhengzhe@fuwai.com
• Study Contact Backup: Name: Chunyu Yu, MD; Email: yuchunyu@fuwai.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Fuwai Hospital
      • Contact: Chunyu Yu, MD; Email: yuchunyu@fuwai.com
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Recruiting
      • Nanjing First Hospital, Nanjing Medical University
      • Contact: Xin Chen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bi-atrial ablation group; Participants in this group will receive mitral valve surgery concomitant with bi-atrial ablation procedure.	Procedure: Bi-atrial ablation; This intervention includes mitral valve surgery concomitant with left atrial ablation and right atrial ablation.
Active Comparator: Left atrial ablation group; 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 alone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Burden of atrial fibrillation	Burden of atrial fibrillation according to 3-day Holter monitoring.	At 12-month after intervention
Major adverse events	Including cardiac death, stroke, heart failure requiring rehospitalization, embolic events or bleeding events requiring rehospitalization.	At 12-month after intervention
Cardiac function	Documented by echocardiography (left ventricular ejection fraction).	At 12-month after intervention

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• Investigators: Study Chair: Zhe Zheng, MD,PhD, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2022
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: August 16, 2021
• First Submitted That Met QC Criteria: August 19, 2021
• First Posted (Actual): August 25, 2021

Study Record Updates

• Last Update Posted (Actual): June 13, 2024
• Last Update Submitted That Met QC Criteria: June 12, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Surgical ablation; Mitral valve surgery; Rheumatic mitral valve disease
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Rheumatic Diseases
• Other Study ID Numbers: 2021-1515

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No