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Concomitant Hybrid Versus Catheter Ablation for Atrial Fibrillation With Hypertrophic Cardiomyopathy

Primary Purpose

Atrial Fibrillation, Cardiomyopathy, Hypertrophic, Radiofrequency Ablation

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
hybrid ablation
catheter ablation
Sponsored by
China National Center for Cardiovascular Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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 severe mitral or tricuspid regurgitation Concomitant with coronary artery disease or valvular disease that needs open heart surgeries 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

hybrid ablation

catheter ablation

Arm Description

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

Participants in this group will receive catheter endocardial ablation only

Outcomes

Primary Outcome Measures

Freedom from documented atrial fibrillation
freedom from documented AF episodes >30 seconds by 72-hour monitoring

Secondary Outcome Measures

All cause mortality
death by any reason
Cardiovascular related mortality
death that related to cardiogenic causes
Stroke
Any stroke or TIA diagnosed in the clinical record after the completion of the intervention
Periferal arterial embolism
Periferal arterial embolism
All-cause rehospitalization
Rehospitalized by any reason
Heart failure related rehospitalization
Rehospitalized by the cause of heart failure episode

Full Information

First Posted
November 2, 2022
Last Updated
February 9, 2023
Sponsor
China National Center for Cardiovascular Diseases
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1. Study Identification

Unique Protocol Identification Number
NCT05610215
Brief Title
Concomitant Hybrid Versus Catheter Ablation for Atrial Fibrillation With Hypertrophic Cardiomyopathy
Official Title
Concomitant Hybrid Versus Catheter Ablation for Reinforcing Therapeutic Effect of Atrial Fibrillation With Hypertrophic Cardiomyopathy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China National Center for Cardiovascular Diseases

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Cardiomyopathy, Hypertrophic, Radiofrequency Ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
hybrid ablation
Arm Type
Experimental
Arm Description
Participants in this group will receive concomitant thoracoscopic epicardial ablation and catheter endocardial ablation
Arm Title
catheter ablation
Arm Type
Active Comparator
Arm Description
Participants in this group will receive catheter endocardial ablation only
Intervention Type
Procedure
Intervention Name(s)
hybrid ablation
Intervention Description
simultaneous thoracoscopic epicardial and catheter endocardial ablation
Intervention Type
Procedure
Intervention Name(s)
catheter ablation
Intervention Description
catheter endocardial ablation
Primary Outcome Measure Information:
Title
Freedom from documented atrial fibrillation
Description
freedom from documented AF episodes >30 seconds by 72-hour monitoring
Time Frame
12 months
Secondary Outcome Measure Information:
Title
All cause mortality
Description
death by any reason
Time Frame
12 months
Title
Cardiovascular related mortality
Description
death that related to cardiogenic causes
Time Frame
12 months
Title
Stroke
Description
Any stroke or TIA diagnosed in the clinical record after the completion of the intervention
Time Frame
12 months
Title
Periferal arterial embolism
Description
Periferal arterial embolism
Time Frame
12 months
Title
All-cause rehospitalization
Description
Rehospitalized by any reason
Time Frame
12 months
Title
Heart failure related rehospitalization
Description
Rehospitalized by the cause of heart failure episode
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 severe mitral or tricuspid regurgitation Concomitant with coronary artery disease or valvular disease that needs open heart surgeries 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhe Zheng, MD.PhD
Phone
+86-010-88396051
Email
zhengzhe@fuwai.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yajie Tang, MD.PhD
Phone
+8618813019554
Email
tangyajietangyajie@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhe Zheng, MD.PhD
Organizational Affiliation
Fuwai Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
City
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhe Zheng, MD,PhD
Phone
+86-010-88396051
Email
zhengzhe@fuwai.com
First Name & Middle Initial & Last Name & Degree
Yajie Tang, MD,PhD
Phone
+8618813019554
Email
tangyajietangyajie@126.com

12. IPD Sharing Statement

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Concomitant Hybrid Versus Catheter Ablation for Atrial Fibrillation With Hypertrophic Cardiomyopathy

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