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

NCT05021601 | Recruiting DMC

• 1 other identifier: 2021-1515
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 2

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.

Conditions

Persistent Atrial Fibrillation

Keywords

Rheumatic mitral valve disease; Surgical ablation; Mitral valve surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Survival rate without permanent pacemaker implantation (Key secondary outcome)

  At 12-month after intervention

• Survival rate without any recurrence of atrial tachyarrhythmias with antiarrhythmic drugs

  At 12-month after intervention

• Burden of atrial fibrillation

  At 12-month after intervention

• Major adverse events

  At 12-month after intervention

• Cardiac function

  At 12-month after intervention

Study Arms (2)

Bi-atrial ablation group

EXPERIMENTAL

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

Procedure: Bi-atrial ablation

Left atrial ablation group

ACTIVE COMPARATOR

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

Procedure: Left atrial ablation

Interventions

Bi-atrial ablation PROCEDURE

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

Bi-atrial ablation group

Left atrial ablation PROCEDURE

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

Left atrial ablation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (2)

Fuwai Hospital

Beijing, Beijing Municipality, China

RECRUITING

Nanjing First Hospital, Nanjing Medical University

Nanjing, Jiangsu, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 36446460 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhe Zheng, MD,PhD

  Chinese Academy of Medical Sciences, Fuwai Hospital

  STUDY CHAIR

Central Study Contacts

Zhe Zheng, MD,PhD

CONTACT

: +86-010-88396051; zhengzhe@fuwai.com

Chunyu Yu, MD

CONTACT

yuchunyu@fuwai.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 25, 2021
• Study Start: May 10, 2022
• Primary Completion: June 1, 2025
• Study Completion: July 1, 2025
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)