Concomitant Hybrid Versus Catheter Ablation for Atrial Fibrillation With Hypertrophic Cardiomyopathy

Study Overview
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Brief Summary
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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.

Detailed Description
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After informed consent, 66 eligible admissions will be recruited in 2 centers. Eligible participants will be randomly divided (1:1) into either hybrid or catheter ablation arms, looking for a primary outcome of 1-year freedom from atrial arrhythmias.

Official Title
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Concomitant Hybrid Versus Catheter Ablation for Reinforcing Therapeutic Effect of Atrial Fibrillation With Hypertrophic Cardiomyopathy

Conditions
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Atrial Fibrillation, Cardiomyopathy, Hypertrophic, Radiofrequency Ablation

Intervention / Treatment
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* Procedure: hybrid ablation
* Procedure: catheter ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients' age is ≥18 y 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) Non-obstructed left ventricular outflow obstruction with peak gradients <30mmHg Concomitant with persistent atrial fibrillation (7 days<sustained episode lasting<3 years) with drug-refractory symptoms. Be able to understand the contents of the trial, and provide written informed consent to participate in this investigation. Exclusion Criteria: Patients with left atrial size >60 mm (2-dimensional echocardiography, parasternal long-axis view) Contraindicated to systemic anticoagulation Left ventricular ejection fraction ≤40% Concomitant with left atrium or left atrial appendage emboli Concomitant with severe mitral or tricuspid regurgitation Concomitant with coronary artery disease or valvular disease that needs open heart surgeries Ischaemic stroke within 2 months Previous ablation history Uncontrolled hyper/hypothyroidism End-staged kidney failure Concomitantly involved in other trials Pregnant or breastfeeding, or women of childbearing age not using a reliable contraceptive method Concomitant with bacteremia or at an active phase of infection Anatomically not suitable for thoracoscopic surgery(history of chest surgery or radiotherapy, etc.) Unwilling or unable to comply with all peri-ablation and follow-up requirements

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hybrid ablation<br>Participants in this group will receive concomitant thoracoscopic epicardial ablation and catheter endocardial ablation | Procedure: hybrid ablation<br>* simultaneous thoracoscopic epicardial and catheter endocardial ablation<br>|
| Active Comparator: catheter ablation<br>Participants in this group will receive catheter endocardial ablation only | Procedure: catheter ablation<br>* catheter endocardial ablation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from documented atrial fibrillation | freedom from documented AF episodes >30 seconds by 72-hour monitoring | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality | death by any reason | 12 months | 
| Cardiovascular related mortality | death that related to cardiogenic causes | 12 months | 
| Stroke | Any stroke or TIA diagnosed in the clinical record after the completion of the intervention | 12 months | 
| Periferal arterial embolism | Periferal arterial embolism | 12 months | 
| All-cause rehospitalization | Rehospitalized by any reason | 12 months | 
| Heart failure related rehospitalization | Rehospitalized by the cause of heart failure episode | 12 months |