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

Last updated: June 12, 2024
Sponsor: China National Center for Cardiovascular Diseases
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dysrhythmia

Chest Pain

Musculoskeletal Diseases

Treatment

Bi-atrial ablation

Left atrial ablation

Clinical Study ID

NCT05021601
2021-1515
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18 years

  • Diagnosis of persistent atrial fibrillation(AF) or long-standing persistent AF bymedical 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 wasdetermined by history of acute rheumatic fever, valve morphology, echocardiographicfindings and pathological diagnosis).

  • Consent to surgical ablation of AF

Exclusion

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 understandthe nature, significance, and scope of study

  • Left atrial diameter>70mm

  • Right ventricular dysfunction (TAPSE<16) or moderate to severe tricuspidregurgitation or pulmonary artery pressure (estimated by echocardiography) >60mmHg

  • Coronary artery bypass grafting is required for participants with coronary heartdisease

  • Previous cardiac surgery

  • Refuse to participate in this study

Study Design

Total Participants: 320
Treatment Group(s): 2
Primary Treatment: Bi-atrial ablation
Phase:
Study Start date:
May 10, 2022
Estimated Completion Date:
July 31, 2025

Study 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.

Connect with a study center

  • Fuwai Hospital

    Beijing, Beijing
    China

    Active - Recruiting

  • Nanjing First Hospital, Nanjing Medical University

    Nanjing, Jiangsu
    China

    Active - Recruiting

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