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
China National Center for Cardiovascular Diseases
320 participants
May 10, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria15
- 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
Interventions
This intervention includes mitral valve surgery concomitant with left atrial ablation and right atrial ablation.
This intervention includes mitral valve surgery concomitant with left atrial ablation alone.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT05021601