Atrial Fibrillation, Cardiomyopathy, Hypertrophic, Radiofrequency Ablation
Conditions
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.
Interventions
PROCEDUREhybrid ablation
simultaneous thoracoscopic epicardial and catheter endocardial ablation
PROCEDUREcatheter ablation
catheter endocardial ablation
Sponsors
China National Center for Cardiovascular Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Periferal arterial embolism | within 12 months | Periferal arterial embolism |
| All cause mortality | within 12 months | death by any reason |
| Cardiovascular related mortality | within 12 months | death that related to cardiogenic causes |
| Cerebral infarction/ischemia | within 12 months | Any stroke or TIA diagnosed in the clinical record after the completion of the intervention |
| Heart failure related rehospitalization | within 3-12 months | Rehospitalized by the cause of heart failure episode |
| Freedom from documented recurrence (on-AADs) | within 3-12 months | freedom from documented AF/AT episodes \>30 seconds (on-AADs) by 72-hour holter monitoring |
| All-cause rehospitalization | within 3-12 months | Rehospitalized by any reason |
Countries
China
Contacts
Primary ContactZhe Zheng, MD.PhD
Backup ContactYajie Tang, MD.PhD
Outcome results
None listed