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Clinical Trials in China / NCT05610215
Recruiting Not applicable

Concomitant Hybrid Versus Catheter Ablation for Atrial Fibrillation With Hypertrophic Cardiomyopathy

NCT05610215 · tracked via the Priya Life Science China tracker
Sponsor
China National Center for Cardiovascular Diseases
Phase
Not applicable
Started
2023-02-11
Last updated
2024-08-30

Condition(s) studied

Atrial FibrillationCardiomyopathy, HypertrophicRadiofrequency Ablation

Investigational drug(s) / intervention(s)

hybrid ablationcatheter ablation

hybrid ablation: simultaneous thoracoscopic epicardial and catheter endocardial ablation

catheter ablation: catheter endocardial ablation

Study 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

Sex
ALL
Min age
18 Years
Max age
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College Beijing China Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05610215 on ClinicalTrials.gov ↗ ← All trials in China