NCT05610215 Concomitant Hybrid Versus Catheter Ablation for Atrial Fibrillation With Hypertrophic Cardiomyopathy
| NCT ID | NCT05610215 |
| Status | Recruiting |
| Phase | — |
| Sponsor | China National Center for Cardiovascular Diseases |
| Condition | Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2023-02-11 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 66 participants in total. It began in 2023-02-11 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Zhe Zheng, MD.PhD
STUDY CHAIR
Chinese Academy of Medical Sciences, Fuwai Hospital
Frequently Asked Questions
Who can join the NCT05610215 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05610215 currently recruiting?
Yes, NCT05610215 is actively recruiting participants. Contact the research team at zhengzhe@fuwai.com for enrollment information.
Where is the NCT05610215 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05610215 clinical trial?
NCT05610215 is sponsored by China National Center for Cardiovascular Diseases. The principal investigator is Zhe Zheng, MD.PhD at Chinese Academy of Medical Sciences, Fuwai Hospital. The trial plans to enroll 66 participants.
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