Concomitant Hybrid Versus Catheter Ablation for Atrial Fibrillation With Hypertrophic Cardiomyopathy

Not Applicable

Recruiting

• Conditions: Cardiomyopathy, Hypertrophic; Atrial Fibrillation; Radiofrequency Ablation
• Interventions: Procedure: hybrid ablation; Procedure: catheter ablation

• Registration Number: NCT05610215
• Lead Sponsor: China National Center for Cardiovascular Diseases

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-11-02
• Study First Submitted QC: 2022-11-02
• Study First Posted: 2022-11-09
• Study Start: 2023-02-11
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-16
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 66

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 severe mitral or tricuspid regurgitation
6. Concomitant with coronary artery disease or valvular disease that needs open heart surgeries
7. Ischaemic stroke within 2 months
8. Previous ablation history
9. Uncontrolled hyper/hypothyroidism
10. End-staged kidney failure
11. Concomitantly involved in other trials
12. Pregnant or breastfeeding, or women of childbearing age not using a reliable contraceptive method
13. Concomitant with bacteremia or at an active phase of infection
14. Anatomically not suitable for thoracoscopic surgery(history of chest surgery or radiotherapy, etc.)
15. Unwilling or unable to comply with all peri-ablation and follow-up requirements

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hybrid ablation	hybrid ablation	Participants in this group will receive concomitant thoracoscopic epicardial ablation and catheter endocardial ablation
catheter ablation	catheter ablation	Participants in this group will receive catheter endocardial ablation only

Primary Outcome Measures

Name	Time	Method
Freedom from documented recurrence (off-AADs)	within 3-12 months	freedom from documented AF/AT episodes \>30 seconds (off-AADs) by 72-hour holter monitoring

Secondary Outcome Measures

Name	Time	Method
Heart failure related rehospitalization	within 3-12 months	Rehospitalized by the cause of heart failure episode
All cause mortality	within 12 months	death by any reason
Cardiovascular related mortality	within 12 months	death that related to cardiogenic causes
Cerebral infarction/ischemia	within 12 months	Any stroke or TIA diagnosed in the clinical record after the completion of the intervention
Periferal arterial embolism	within 12 months	Periferal arterial embolism
All-cause rehospitalization	within 3-12 months	Rehospitalized by any reason
Freedom from documented recurrence (on-AADs)	within 3-12 months	freedom from documented AF/AT episodes \>30 seconds (on-AADs) by 72-hour holter monitoring

Trial Locations

Locations (1)

Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College; 🇨🇳 Beijing, China