Concomitant Hybrid Versus Catheter Ablation for Atrial Fibrillation With Hypertrophic Cardiomyopathy

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Atrial Fibrillation; Cardiomyopathy, Hypertrophic; Radiofrequency Ablation
• Intervention / Treatment: Procedure: hybrid ablation; Procedure: catheter ablation

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 Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhe Zheng, MD.PhD; Phone Number: +86-010-88396051; Email: zhengzhe@fuwai.com
• Study Contact Backup: Name: Yajie Tang, MD.PhD; Phone Number: +8618813019554; Email: tangyajietangyajie@126.com

Study Locations

• China
  • Beijing, China
    • Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
    • Contact: Yajie Tang, MD,PhD; Phone Number: +8618813019554; Email: tangyajietangyajie@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: hybrid ablation; Participants in this group will receive concomitant thoracoscopic epicardial ablation and catheter endocardial ablation	Procedure: hybrid ablation; simultaneous thoracoscopic epicardial and catheter endocardial ablation
ACTIVE_COMPARATOR: catheter ablation; Participants in this group will receive catheter endocardial ablation only	Procedure: catheter ablation; catheter endocardial ablation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• Investigators: Study Chair: Zhe Zheng, MD.PhD, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2023
• Primary Completion (ANTICIPATED): December 1, 2024
• Study Completion (ANTICIPATED): February 1, 2025

Study Registration Dates

• First Submitted: November 2, 2022
• First Submitted That Met QC Criteria: November 2, 2022
• First Posted (ACTUAL): November 9, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 9, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Arrhythmias, Cardiac; Aortic Valve Disease; Heart Valve Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Atrial Fibrillation; Hypertrophy; Cardiomyopathies; Cardiomyopathy, Hypertrophic
• Other Study ID Numbers: 2022-1736

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No