hybrid ablation: simultaneous thoracoscopic epicardial and catheter endocardial ablation
catheter ablation: catheter endocardial ablation
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Patients' age is ≥18 y
2. 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)
3. Non-obstructed left ventricular outflow obstruction with peak gradients \<30mmHg
4. Concomitant with persistent atrial fibrillation (7 days\<sustained episode lasting\<3 years) with drug-refractory symptoms.
5. Be able to understand the contents of the trial, and provide written informed consent to participate in this investigation.
Exclusion Criteria:
1. Patients with left atrial size \>60 mm (2-dimensional echocardiography, parasternal long-axis view)
2. Contraindicated to systemic anticoagulation
3. Left ventricular ejection fraction ≤40%
4. Concomitant with left atrium or left atrial appendage emboli
5. Concomitant with a coronary or valvular disease that indicates intervention
6. Ischaemic stroke within 2 months
7. Previous ablation history
8. Uncontrolled hyper/hypothyroidism
9. End-staged kidney failure
10. Concomitantly involved in other trials
11. Pregnant or breastfeeding, or women of childbearing age not using a reliable contraceptive method
12. Concomitant with bacteremia or at an active phase of infection
13. Anatomically not suitable for thoracoscopic surgery(history of chest surgery or radiotherapy, etc.)
14. Unwilling or unable to comply with all peri-ablation and follow-up requirements
Primary outcome measure(s)
Freedom from documented recurrence (off-AADs) — within 3-12 months freedom from documented AF/AT episodes \>30 seconds (off-AADs) by 72-hour holter monitoring
Trial sites (1)
Facility
City
Region
Status
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing
China
Recruiting
More China National Center for Cardiovascular Diseases trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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