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

NCT ID: NCT05021601

Last Updated: 2024-06-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-10
• Study Completion Date: 2025-07-31

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.

Conditions

Persistent Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Bi-atrial ablation group

Participants in this group will receive mitral valve surgery concomitant with bi-atrial ablation procedure.

Group Type: EXPERIMENTAL

Bi-atrial ablation

Intervention Type: PROCEDURE

This intervention includes mitral valve surgery concomitant with left atrial ablation and right atrial ablation.

Left atrial ablation group

Participants in this group will receive mitral valve surgery concomitant with left atrial ablation procedure.

Group Type: ACTIVE_COMPARATOR

Left atrial ablation

Intervention Type: PROCEDURE

This intervention includes mitral valve surgery concomitant with left atrial ablation alone.

Interventions

Bi-atrial ablation

This intervention includes mitral valve surgery concomitant with left atrial ablation and right atrial ablation.

Intervention Type: PROCEDURE

Left atrial ablation

This intervention includes mitral valve surgery concomitant with left atrial ablation alone.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhe Zheng, MD,PhD

Role: STUDY_CHAIR

Chinese Academy of Medical Sciences, Fuwai Hospital

Locations

Fuwai Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Nanjing First Hospital, Nanjing Medical University

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhe Zheng, MD,PhD

Role: CONTACT

zhengzhe@fuwai.com

: +86-010-88396051

Chunyu Yu, MD

Role: CONTACT

yuchunyu@fuwai.com

Facility Contacts

Chunyu Yu, MD

Role: primary

yuchunyu@fuwai.com

Xin Chen

Role: primary

References

Yu C, Li H, Wang Y, Chen S, Zhao Y, Zheng Z. Bi-atrial versus left atrial ablation for patients with rheumatic mitral valve disease and non-paroxysmal atrial fibrillation (ABLATION): rationale, design and study protocol for a multicentre randomised controlled trial. BMJ Open. 2022 Nov 29;12(11):e064861. doi: 10.1136/bmjopen-2022-064861.

Reference Type: DERIVED

PMID: 36446460 (View on PubMed)

Other Identifiers

2021-1515

Identifier Type: -

Identifier Source: org_study_id