A Study of Multi-electrode Circular Irreversible Electroporation (IRE) Catheter and Multi-Channel IRE Generator in Paroxysmal Atrial Fibrillation (AF)

NCT05552963 | Completed Results DMC FDA Device

• 1 other identifier: BWI202107
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to evaluate the long term off-Antiarrhythmic Drug (AAD) effectiveness of Biosense Webster, Inc. Irreversible Electroporation (BWI IRE) system in treatment of participants with symptomatic drug refractory paroxysmal atrial fibrillation (PAF).

Conditions

Refractory Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Long-term Effectiveness

  Long-term effectiveness was defined as freedom from documented asymptomatic and symptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL; of unknown origin) episodes based on electrocardiographic data (greater than equal to \[\>=\] 30 seconds on arrhythmia monitoring device) through the effectiveness evaluation period (Day 91 through Day 365 post index procedure) and freedom from the following failure modes : freedom from acute procedural failure, freedom from non-study catheter failure, freedom from repeat ablation failure, freedom from direct Current (DC) cardioversion failure, freedom from recurrence (captured on 12-lead electrocardiogram \[ECG\]) failure, and freedom from anti-arrhythmic drug failure. AFL of unknown origin was defined as all AFL except those Cavo-Tricuspid Isthmus (CTI) dependent AFL as confirmed by accepted electrophysiology (EP) maneuvers (for example, entrainment or activation mapping) in an EP study.

  From Day 91 up to Day 365 post-procedure on Day 0

Secondary Outcomes (7)

• Percentage of Participants Experiencing Primary Adverse Event (PAE)

  Within 7 days post-procedure on Day 0

• Percentage of Participants Experiencing Serious Adverse Event (SAE) Within 7 Days, 8-30 Days and >30 Days of Initial Ablation Procedure

  From day of procedure (Day 0) up to 12 months

• Percentage of Participants With Acute Procedural Success

  On the day of procedure (Day 0)

• Percentage of Participants With Acute Reconnection

  On the day of procedure (Day 0)

• Percentage of Pulmonary Veins (PVs) With Acute Reconnection

  On the day of procedure (Day 0)

Study Arms (1)

Irreversible Electroporation (IRE) System

EXPERIMENTAL

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.

Device: Multi-Channel Irreversible Electroporation (IRE) Generator; Device: Multi-Channel Circular IRE Catheter

Interventions

Multi-Channel Irreversible Electroporation (IRE) Generator DEVICE

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.

Also known as: D-1417-01-I

Irreversible Electroporation (IRE) System

Multi-Channel Circular IRE Catheter DEVICE

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.

Also known as: D-1412-01-SI

Irreversible Electroporation (IRE) System

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with symptomatic paroxysmal atrial fibrillation (PAF) (Physician's note indicating recurrent self-terminating atrial fibrillation \[AF\]). At least one electrocardiographically documented AF episode within twelve (12) months prior to enrollment. Electrocardiographic documentation may include, but is not limited to, electrocardiogram (ECG), Holter monitor, or telemetry strip
• 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

You may not qualify if:

• AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (Example, untreated documented obstructive sleep apnea and acute alcohol toxicity)
• 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)

Sponsors & Collaborators

• Biosense Webster, Inc.: lead

Study Sites (6)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Location

The first affiliated hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

The first affiliated hospital of Dalian Medical University

Dalian, Liaoning, China

Location

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Electroporation; Radionuclide Generators

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques; Radiation Equipment and Supplies; Equipment and Supplies

Results Point of Contact

• Title: Executive Medical Director
• Organization: Janssen Research and Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Jianzeng Dong

  The First Affiliated Hospital of Zhengzhou University

  STUDY CHAIR

• Shaowen Liu

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

• Hailong Tao

  The First Affiliated Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

• Hua Fu

  West China Hospital

  PRINCIPAL INVESTIGATOR

• Yumei Xue

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

• Heng Cai

  Tianjin Medical University General Hospital

  PRINCIPAL INVESTIGATOR

• Lianjun Gao

  The First Affiliated Hospital of Dalian Medical University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 23, 2022
• Study Start: December 7, 2022
• Primary Completion: December 18, 2024
• Study Completion: December 18, 2024
• Last Updated: January 6, 2026
• Results First Posted: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

CN (6)