A Study of Multi-electrode Circular Irreversible Electroporation (IRE) Catheter and Multi-Channel IRE Generator in Paroxysmal Atrial Fibrillation (AF)
NCT ID: NCT05552963
Last Updated: 2026-01-06
Study Results
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View full resultsBasic Information
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COMPLETED
NA
142 participants
INTERVENTIONAL
2022-12-07
2024-12-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Irreversible Electroporation (IRE) System
Participants with symptomatic drug refractory paroxysmal atrial fibrillation (PAF) and indicated for catheter ablation will be treated with the IRE system which includes multi-electrode circular IRE catheter and the multi-channel IRE generator.
Multi-Channel Irreversible Electroporation (IRE) Generator
The multi-channel IRE Generator is intended for use during cardiac Pulsed Field Ablation (PFA) therapy. This device is used in conjunction with a compatible ablation catheter to create a closed electrical circuit capable of delivering pulsed electrical field energy.
Multi-Channel Circular IRE Catheter
The multi-channel circular IRE Catheter is indicated for use in catheter-based cardiac electrophysiological mapping (stimulating and recording) and when used with an IRE Generator, for cardiac ablation.
Interventions
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Multi-Channel Irreversible Electroporation (IRE) Generator
The multi-channel IRE Generator is intended for use during cardiac Pulsed Field Ablation (PFA) therapy. This device is used in conjunction with a compatible ablation catheter to create a closed electrical circuit capable of delivering pulsed electrical field energy.
Multi-Channel Circular IRE Catheter
The multi-channel circular IRE Catheter is indicated for use in catheter-based cardiac electrophysiological mapping (stimulating and recording) and when used with an IRE Generator, for cardiac ablation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Failed at least one Class I or Class III antiarrhythmic drug (AAD) as evidenced by recurrent symptomatic AF, contraindicated or intolerable to both Class I and Class III AAD
* Able and willing to comply with all pre-procedure, post-procedure, and follow-up testing and visit requirements
* Willing and capable of providing consent
Exclusion Criteria
* Previous left atrium (LA) ablation or surgery
* Participants known to require ablation outside the pulmonary vein (PV) region (atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, atrial tachycardia, atrial flutter of unknown origin, ventricular tachycardia and Wolff-Parkinson-White)
* Previously diagnosed with persistent AF (greater than \[\>\] 7 days in duration)
* Severe dilatation of the LA (documented LAD \>50 millimeters \[mm\] antero-posterior diameter by transthoracic echocardiography (TTE) within 6 month prior to enrollment)
18 Years
80 Years
ALL
No
Sponsors
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Biosense Webster, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jianzeng Dong
Role: STUDY_CHAIR
The First Affiliated Hospital of Zhengzhou University
Shaowen Liu
Role: PRINCIPAL_INVESTIGATOR
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Hailong Tao
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Zhengzhou University
Hua Fu
Role: PRINCIPAL_INVESTIGATOR
West China Hospital
Yumei Xue
Role: PRINCIPAL_INVESTIGATOR
Guangdong Provincial People's Hospital
Heng Cai
Role: PRINCIPAL_INVESTIGATOR
Tianjin Medical University General Hospital
Lianjun Gao
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Dalian Medical University
Locations
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Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
The first affiliated hospital of Zhengzhou University
Zhengzhou, Henan, China
The first affiliated hospital of Dalian Medical University
Dalian, Liaoning, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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BWI202107
Identifier Type: OTHER
Identifier Source: secondary_id
BWI202107
Identifier Type: -
Identifier Source: org_study_id
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