Concomitant Hybrid Versus Catheter Ablation for Reinforcing Therapeutic Effect of Atrial Fibrillation With Hypertrophic Cardiomyopathy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- China National Center for Cardiovascular Diseases
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Freedom from documented recurrence (off-AADs)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
After informed consent, 66 eligible admissions will be recruited in 2 centers. Eligible participants will be randomly divided (1:1) into either hybrid or catheter ablation arms, looking for a primary outcome of 1-year freedom from atrial arrhythmias.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
- •Be able to understand the contents of the trial, and provide written informed consent to participate in this investigation.
Exclusion Criteria
- •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
- •Concomitant with severe mitral or tricuspid regurgitation
- •Concomitant with coronary artery disease or valvular disease that needs open heart surgeries
- •Ischaemic stroke within 2 months
- •Previous ablation history
- •Uncontrolled hyper/hypothyroidism
- •End-staged kidney failure
Outcomes
Primary Outcomes
Freedom from documented recurrence (off-AADs)
Time Frame: within 3-12 months
freedom from documented AF/AT episodes \>30 seconds (off-AADs) by 72-hour holter monitoring
Secondary Outcomes
- All cause mortality(within 12 months)
- Cardiovascular related mortality(within 12 months)
- Cerebral infarction/ischemia(within 12 months)
- Periferal arterial embolism(within 12 months)
- All-cause rehospitalization(within 3-12 months)
- Freedom from documented recurrence (on-AADs)(within 3-12 months)
- Heart failure related rehospitalization(within 3-12 months)