Comparing hybrid and catheter ablation for atrial fibrillation in patients with hypertrophic cardiomyopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.