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

Primary Purpose

Refractory Paroxysmal Atrial Fibrillation

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Multi-Channel Irreversible Electroporation (IRE) Generator
Multi-Channel Circular IRE Catheter
Sponsored by
Biosense Webster, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory Paroxysmal Atrial Fibrillation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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, 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)

Sites / Locations

  • Guangdong Provincial People's Hospital
  • The first affiliated hospital of Zhengzhou UniversityRecruiting
  • The first affiliated hospital of Dalian Medical University
  • Shanghai General HospitalRecruiting
  • West China Hospital of Sichuan University
  • Tianjin Medical University General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Irreversible Electroporation (IRE) System

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of Participants with Long Term Effectiveness Without Antiarrhythmic Drug (AAD) Use
Long term effectiveness is defined as freedom more than or equal to (>=) 30 seconds from documented asymptomatic and symptomatic atrial fibrillation (AF), atrial tachycardia (AT), and atrial flutter (AFL) of unknown origin based on electrocardiographic data during the effectiveness evaluation period.

Secondary Outcome Measures

Number of Participants with Acute Procedural Success
Acute Procedural Success defined as confirmation of entrance block in all clinically relevant targeted pulmonary vein (PVs) after adenosine/ isoproterenol challenge. Touching up with focal catheter will be considered as acute procedural failure.
Number of Participants with Acute Reconnection
Acute reconnection identified by adenosine/isoproterenol challenge. Among all clinically relevant targeted PVs and by subject.
Number of Participants with Rate of PV
Rate of PV ablation by a non-study catheter (touch-up) among all clinically relevant targeted PVs and by subject.
Number of Participants with Rate of Repeated Ablation
Rate of repeated ablation within the 12 months follow-up period, including timing (blanking period or after blanking) and rate of PV reconnection.
Number of Participants with Primary Adverse Events (PAEs)
An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) occurring during a clinical study, whether or not related to the study device or ablation procedure.
Number of Participants with Serious Adverse Events (SAEs) Within 7 days, 8-30 Days and More Than 30 Days of Initial Ablation Procedure
An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) occurring during a clinical study, whether or not related to the study device or ablation procedure.
Number of Participants with AEs
An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) occurring during a clinical study, whether or not related to the study device or ablation procedure.
Number of Participants with SAEs
An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) occurring during a clinical study, whether or not related to the study device or ablation procedure.

Full Information

First Posted
September 21, 2022
Last Updated
October 10, 2023
Sponsor
Biosense Webster, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05552963
Brief Title
A Study of Multi-electrode Circular Irreversible Electroporation (IRE) Catheter and Multi-Channel IRE Generator in Paroxysmal Atrial Fibrillation (AF)
Acronym
AFIRE
Official Title
A Prospective, Multicenter, Single Arm With Performance Goal Study to Evaluate Safety and Effectiveness of Multi-electrode Circular IRE Catheter and Multi-Channel IRE Generator in Paroxysmal AF
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 7, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biosense Webster, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Paroxysmal Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
147 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Irreversible Electroporation (IRE) System
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Multi-Channel Irreversible Electroporation (IRE) Generator
Other Intervention Name(s)
D-1417-01-I
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Multi-Channel Circular IRE Catheter
Other Intervention Name(s)
D-1412-01-SI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants with Long Term Effectiveness Without Antiarrhythmic Drug (AAD) Use
Description
Long term effectiveness is defined as freedom more than or equal to (>=) 30 seconds from documented asymptomatic and symptomatic atrial fibrillation (AF), atrial tachycardia (AT), and atrial flutter (AFL) of unknown origin based on electrocardiographic data during the effectiveness evaluation period.
Time Frame
91-365 days post index procedure
Secondary Outcome Measure Information:
Title
Number of Participants with Acute Procedural Success
Description
Acute Procedural Success defined as confirmation of entrance block in all clinically relevant targeted pulmonary vein (PVs) after adenosine/ isoproterenol challenge. Touching up with focal catheter will be considered as acute procedural failure.
Time Frame
Up to 12 months
Title
Number of Participants with Acute Reconnection
Description
Acute reconnection identified by adenosine/isoproterenol challenge. Among all clinically relevant targeted PVs and by subject.
Time Frame
Up to 12 months
Title
Number of Participants with Rate of PV
Description
Rate of PV ablation by a non-study catheter (touch-up) among all clinically relevant targeted PVs and by subject.
Time Frame
Up to 12 months
Title
Number of Participants with Rate of Repeated Ablation
Description
Rate of repeated ablation within the 12 months follow-up period, including timing (blanking period or after blanking) and rate of PV reconnection.
Time Frame
Up to 12 months
Title
Number of Participants with Primary Adverse Events (PAEs)
Description
An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) occurring during a clinical study, whether or not related to the study device or ablation procedure.
Time Frame
Within 7 days of ablation procedure
Title
Number of Participants with Serious Adverse Events (SAEs) Within 7 days, 8-30 Days and More Than 30 Days of Initial Ablation Procedure
Description
An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) occurring during a clinical study, whether or not related to the study device or ablation procedure.
Time Frame
Within 7 days, 8-30 days and more than (>) 30 days of initial ablation procedure
Title
Number of Participants with AEs
Description
An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) occurring during a clinical study, whether or not related to the study device or ablation procedure.
Time Frame
Up to 12 months
Title
Number of Participants with SAEs
Description
An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) occurring during a clinical study, whether or not related to the study device or ablation procedure.
Time Frame
Up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
+86 15210099156
Email
yzhan365@its.jnj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianzeng Dong
Organizational Affiliation
The First Affiliated Hospital of Zhengzhou University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Shaowen Liu
Organizational Affiliation
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hailong Tao
Organizational Affiliation
The First Affiliated Hospital of Zhengzhou University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hua Fu
Organizational Affiliation
West China Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yumei Xue
Organizational Affiliation
Guangdong Provincial People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Heng Cai
Organizational Affiliation
Tianjin Medical University General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lianjun Gao
Organizational Affiliation
The First Affiliated Hospital of Dalian Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yumei Xue
Email
xymgdci@163.com
Facility Name
The first affiliated hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hailong Tao
Email
hailongtao@163.com
Facility Name
The first affiliated hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lianjun Gao
Email
gaoljmd@126.com
Facility Name
Shanghai General Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaowen Liu
Email
shaowen.liu@hotmail.com
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heng Cai
Email
caihengch@163.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
IPD Sharing URL
http://yoda.yale.edu

Learn more about this trial

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

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