Concomitant Hybrid Versus Catheter Ablation for Atrial Fibrillation With Hypertrophic Cardiomyopathy

Launched by CHINA NATIONAL CENTER FOR CARDIOVASCULAR DISEASES · Nov 2, 2022

Keywords

ClinConnect Summary

This clinical trial is looking to find out which treatment works better for patients with a specific heart condition called hypertrophic cardiomyopathy who also have persistent atrial fibrillation, a type of irregular heartbeat. The study is comparing two methods: a hybrid approach that combines two types of heart procedures—catheter ablation and thoracoscopic epicardial ablation—against catheter ablation alone. The goal is to see if the hybrid method can help patients maintain a normal heart rhythm more effectively than just using the catheter ablation.

To join the trial, participants need to be at least 18 years old and have been diagnosed with hypertrophic cardiomyopathy along with persistent atrial fibrillation that hasn’t improved with medications. They should not have certain heart conditions or other serious health issues. If eligible, participants can expect to be part of a study that may help improve treatment options for people with similar heart problems in the future. It’s important for potential participants to understand what the study involves and to provide informed consent before joining.

Gender

ALL

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