Concomitant Hybrid Versus Catheter Ablation for Atrial Fibrillation With Hypertrophic Cardiomyopathy

NCT05610215 | Recruiting DMC

• 1 other identifier: 2022-1736
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Cardiomyopathy, Hypertrophic; Radiofrequency Ablation

Outcome Measures

Primary Outcomes (1)

• Freedom from documented recurrence (off-AADs)

  freedom from documented AF/AT episodes \>30 seconds (off-AADs) by 72-hour holter monitoring

  within 3-12 months

Secondary Outcomes (7)

• All cause mortality

  within 12 months

• Cardiovascular related mortality

  within 12 months

• Cerebral infarction/ischemia

  within 12 months

• Periferal arterial embolism

  within 12 months

• All-cause rehospitalization

  within 3-12 months

Study Arms (2)

hybrid ablation

EXPERIMENTAL

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

Procedure: hybrid ablation

catheter ablation

ACTIVE COMPARATOR

Participants in this group will receive catheter endocardial ablation only

Procedure: catheter ablation

Interventions

hybrid ablation PROCEDURE

simultaneous thoracoscopic epicardial and catheter endocardial ablation

hybrid ablation

catheter ablation PROCEDURE

catheter endocardial ablation

catheter ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 a coronary or valvular disease that indicates intervention
• 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

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, China

RECRUITING

Related Publications (1)

• Tang Y, Li L, Chen S, Xue Y, Guo H, Song L, Tang M, Yao Y, Zheng Z. Hybrid versus catheter ablation for Hypertrophic CardioMyopathy with Atrial Fibrillation (HCM-AF): study protocol for a randomised controlled trial. BMJ Open. 2024 Oct 9;14(10):e089284. doi: 10.1136/bmjopen-2024-089284.

  PMID: 39384237 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Cardiomyopathy, Hypertrophic

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiomyopathies; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Zhe Zheng, MD.PhD

  Chinese Academy of Medical Sciences, Fuwai Hospital

  STUDY CHAIR

Central Study Contacts

Zhe Zheng, MD.PhD

CONTACT

+86-010-88396051; zhengzhe@fuwai.com

Yajie Tang, MD.PhD

CONTACT

+8618813019554; tangyajietangyajie@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 9, 2022
• Study Start: February 11, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 30, 2024

Record last verified: 2024-08

Locations

CN (1)