About this trial
The goal of this clinical trial is to compare the rhythm control effect in hypertrophic non-obstructive patients with non-paroxysmal atrial fibrillation by either concomitant catheter endocardial and thoracoscopic epicardial ablation or catheter ablation alone. The study aims to see if concomitant hybrid ablation can more effectively achieve rhythm control effect than catheter ablation alone in non-paroxysmal atrial fibrillation patients with hypertrophic cardiomyopathy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients' age is ≥18 y
Clinically diagnosed hypertrophic cardiomyopathy (any left ventricular wall segment thickness ≥15 mm in genetical negative (or unknown genetical status) patients or ≥13mm in genetical positive ones-as measured by any imaging technique (echocardiography, cardiac magnetic resonance imaging or computed tomography)-that is not explained solely by loading conditions)
Non-obstructed left ventricular outflow obstruction with peak gradients <30mmHg
Concomitant with persistent atrial fibrillation (7 days<sustained episode lasting<3 years) with drug-refractory symptoms.
Disqualifiers
Patients with left atrial size >60 mm (2-dimensional echocardiography, parasternal long-axis view)
Contraindicated to systemic anticoagulation
Left ventricular ejection fraction ≤40%
Concomitant with left atrium or left atrial appendage emboli
Trial design
Parallel
Treatments tested in this trial
hybrid ablation
Procedure/Surgerysimultaneous thoracoscopic epicardial and catheter endocardial ablation
catheter ablation
Procedure/Surgerycatheter endocardial ablation
Treatment groups
Trial outcomes
Primary outcomes
Freedom from documented recurrence (off-AADs)
freedom from documented AF/AT episodes \>30 seconds (off-AADs) by 72-hour holter monitoring
Secondary outcomes
All cause mortality
death by any reason
Cardiovascular related mortality
death that related to cardiogenic causes
Cerebral infarction/ischemia
Any stroke or TIA diagnosed in the clinical record after the completion of the intervention
Periferal arterial embolism
Periferal arterial embolism
Sponsors and contacts
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