Comparing two procedures to restore heart rhythm in hypertrophic cardiomyopathy with atrial fibrillation
Compares hybrid ablation with catheter ablation in adults with thickened hearts and atrial fibrillation.
Plain-language title generated from the registry record
Registry title: Concomitant Hybrid Versus Catheter Ablation for Atrial Fibrillation With Hypertrophic Cardiomyopathy
Key facts
- Where
- Beijing, ChinaSee the site
Where in China
- Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- China National Center for Cardiovascular Diseases
- Trial code
- NCT05610215
- Record updated
- 30 August 2024
- Original description
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.Read full original descriptionShow less
Concomitant Hybrid Versus Catheter Ablation for Reinforcing Therapeutic Effect of Atrial Fibrillation With Hypertrophic Cardiomyopathy
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.
Inclusion: 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: Concomitant with left atrium or left atrial appendage emboli; Concomitant with a coronary or valvular disease that indicates intervention; Previous ablation history; Concomitant with bacteremia or at an active phase of infection; Ischaemic stroke within 2 months; End-staged kidney failure; Anatomically not suitable for thoracoscopic surgery(history of chest surgery or radiotherapy, etc.); Left ventricular ejection fraction ≤40%; Pregnant or breastfeeding, or women of childbearing age not using a reliable contraceptive method; Patients with left atrial size >60 mm (2-dimensional echocardiography, parasternal long-axis view); Contraindicated to systemic anticoagulation; Uncontrolled hyper/hypothyroidism; Concomitantly involved in other trials; Unwilling or unable to comply with all peri-ablation and follow-up requirements.