Comparing hybrid and catheter ablation for atrial fibrillation in patients with hypertrophic cardiomyopathy
Concomitant Hybrid Versus Catheter Ablation for Reinforcing Therapeutic Effect of Atrial Fibrillation With Hypertrophic Cardiomyopathy
This study is testing whether a new hybrid ablation method works better than traditional catheter ablation for controlling heart rhythm in patients with hypertrophic cardiomyopathy and ongoing atrial fibrillation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | China National Center for Cardiovascular Diseases Government |
| Locations | 1 site (Beijing) |
| Trial ID | NCT05610215 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of hybrid ablation versus catheter ablation in achieving rhythm control in patients with hypertrophic cardiomyopathy and non-paroxysmal atrial fibrillation. A total of 66 eligible patients will be randomly assigned to receive either hybrid ablation, which combines both endocardial and epicardial approaches, or catheter ablation alone. The primary outcome will be the rate of freedom from atrial arrhythmias after one year. The study is being conducted at two centers, focusing on patients who have not responded to drug therapy for their symptoms.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with hypertrophic cardiomyopathy and persistent atrial fibrillation that has not responded to medication.
Not a fit: Patients with significant left atrial enlargement, contraindications to anticoagulation, or severely reduced left ventricular function may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with hypertrophic cardiomyopathy and atrial fibrillation, potentially improving their quality of life.
How similar studies have performed: While hybrid ablation techniques have been explored in other studies, this specific comparison in the context of hypertrophic cardiomyopathy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Beijing
- Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Zhe Zheng, MD.PhD
- Email: zhengzhe@fuwai.com
- Phone: +86-010-88396051
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.