Bi-atrial Versus Left Atrial Ablation for Patients With Rheumatic Mitral Valve Disease and Non-pa… (NCT05021601) | Clinical Trial Compass
RecruitingNot Applicable
Bi-atrial Versus Left Atrial Ablation for Patients With Rheumatic Mitral Valve Disease and Non-paroxysmal Atrial Fibrillation
China320 participantsStarted 2022-05-10
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Survival rate without any recurrence of atrial tachyarrhythmias in the absence of antiarrhythmic drugs
Timeframe: At 12-month after intervention
Trial details
NCT IDNCT05021601
SponsorChina National Center for Cardiovascular Diseases