Concomitant Hybrid Versus Catheter Ablation for Atrial Fibrillation With Hypertrophic Cardiomyopathy

National Center for Cardiovascular Diseases

Status: Enrolling

Conditions: Atrial Fibrillation; Radiofrequency Ablation; Cardiomyopathy, Hypertrophic

Treatments: Procedure: catheter ablation; Procedure: hybrid ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT05610215

2022-1736

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 2 patient groups

hybrid ablation

Experimental group

Description:

Participants in this group will receive concomitant thoracoscopic epicardial ablation and catheter endocardial ablation

Treatment:

Procedure: hybrid ablation

catheter ablation

Active Comparator group

Description:

Participants in this group will receive catheter endocardial ablation only

Treatment:

Procedure: catheter ablation