Concomitant Hybrid Versus Catheter Ablation for Atrial Fibrillation With Hypertrophic Cardiomyopathy

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05610215
• Other study ID #: 2022-1736
• Status: Recruiting
• Phase: N/A
• Start date: February 11, 2023
• Est. completion date: December 2026

Study information

• Verified date: May 2024
• Source: China National Center for Cardiovascular Diseases
• Contact: Zhe Zheng, MD.PhD
• Phone: +86-010-88396051
• Email: zhengzhe[@]fuwai.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophy
• Radiofrequency Ablation

Intervention

Procedure:
• hybrid ablation
simultaneous thoracoscopic epicardial and catheter endocardial ablation
• catheter ablation
catheter endocardial ablation

Locations

Country	Name	City	State
China	Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from documented recurrence (off-AADs)	freedom from documented AF/AFL episodes >30 seconds (off-AADs) by 72-hour monitoring	within 3-12 months
Secondary	All cause mortality	death by any reason	12 months
Secondary	Cardiovascular related mortality	death that related to cardiogenic causes	12 months
Secondary	Stroke	Any stroke or TIA diagnosed in the clinical record after the completion of the intervention	12 months
Secondary	Periferal arterial embolism	Periferal arterial embolism	12 months
Secondary	All-cause rehospitalization	Rehospitalized by any reason	within 3-12 months
Secondary	Heart failure related rehospitalization	Rehospitalized by the cause of heart failure episode	within 3-12 months
Secondary	Freedom from documented recurrence (on-AADs)	freedom from documented AF/AFL episodes >30 seconds (on-AADs) by 72-hour monitoring	within 3-12 months