A Study for Treatment of Paroxysmal Atrial Fibrillation (PAF) by Pulsed Field Ablation (PFA) System With Irreversible Electroporation (IRE) (inspIRE)

Pulsed Field Ablation (PFA) System for the Treatment of Paroxysmal Atrial Fibrillation (PAF) by Irreversible Electroporation (IRE)

The primary objective is to demonstrate safety and long-term effectiveness of the irreversible electroporation (IRE) system (Circular IRE Catheter and IRE Generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF).

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Pulsed Field Ablation (PFA) Therapy

• Study Type: Interventional
• Enrollment (Actual): 272
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • Medical University Graz
  • Linz, Austria, 4020
    • Ordensklinikum Linz Elisabethinen
• Belgium
  • Aalst, Belgium, 9300
    • OLV Aalst
  • Brugge, Belgium, 8000
    • AZ Sint-Jan Brugge
  • Genk, Belgium, 3600
    • Ziekenhuis Oost-Limburg Genk Campus Sint-Jan
  • Hasselt, Belgium, 3500
    • Jessa Ziekenhuis - Campus Virga Jesse
• Canada
  • Newmarket, Canada, ON L3Y 2P9
    • Southlake Regional Health Centre
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre
• Croatia
  • Split, Croatia, 21000
    • University Hospital Center Split
• Czechia
  • Prague, Czechia, 150 30 District 5
    • Nemocnice na Homolce
• France
  • Bordeaux, France, 33600
    • Centre Hospitalier Universitaire (CHU) de Bordeaux
• Italy
  • Acquaviva delle Fonti, Italy, 70021
    • Ospedale Generale Regionale "F. Miulli"
• Lithuania
  • Vilnius, Lithuania, 8661
    • Vilnius University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosed with Symptomatic paroxysmal atrial fibrillation (PAF)
• Selected for atrial fibrillation (AF) ablation procedure by pulmonary vein isolation (PVI)
• Failed at least one antiarrhythmic drug (AAD) (class I to IV) as evidenced by recurrent symptomatic atrial fibrillation AF, or intolerable or contraindicated to the AAD
• Willing and capable of providing consent
• Able and willing to comply with all pre-, post- and follow-up testing and requirements

Exclusion Criteria:

• AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
• Previous left atrium (LA) ablation or surgery
• Participant known to require ablation outside the PV region (example. cavotricuspid isthmus [CTI] 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 (LAD >50 millimeter (mm) antero-posterior diameter in case of transthoracic echocardiography (TTE))

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Participants with Paroxysmal Atrial Fibrillation (PAF); Participants with PAF and who are candidates for catheter ablation will be enrolled.

Device: Pulsed Field Ablation (PFA) Therapy; Participants will undergo PFA therapy with a compatible ablation catheter when used with Multi-Channel irreversible electroporation (IRE) Generator (deliver trains of high-voltage bipolar pulses of short duration on separate channels to a multi-electrode ablation catheter) and Circular IRE Catheter (indicated for use in catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used with an IRE Generator, for cardiac ablation).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Primary Adverse Events (PAEs)	An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. The primary safety endpoint was the incidence of PAEs (within 7 days of the initial mapping and ablation procedure). PAEs included the following AEs: Atrio-esophageal fistula, cardiac tamponade/perforation, device or procedure related death, major vascular access complication/bleeding, myocardial infarction, pericarditis, phrenic nerve paralysis (permanent), pulmonary vein stenosis, stroke/cerebrovascular accident (CVA), thromboembolism, and transient ischemic attack (TIA).	Within 7 days post-procedure on Day 0
Kaplan-Meier Estimates of the Success Rate of Freedom From Documented (Symptomatic and Asymptomatic) Atrial Arrhythmia (Atrial Fibrillation [AF], Atrial Tachycardia [AT], or Atrial Flutter [AFL]) Episodes From Day 91 to Day 365 Post Index Procedure	Kaplan-Meier estimates of the success rate of freedom from primary effectiveness failure, that is, documented (symptomatic and asymptomatic) atrial arrhythmia (AF, AT, or AFL) recurrence based on electrocardiographic data (>=30 seconds on arrhythmia monitoring device) from Day 91 to Day 365 post index procedure, was reported. Acute procedural failure defined as failure to confirm entrance block in all PVs except those that are silent and/or cannot be cannulated post-procedure, use of a non-study catheter for PV isolation, or failure to have PFA delivery with the study catheter due to IRE system malfunctions, was also considered a long-term effectiveness failure.	From Day 91 up to Day 365 post index procedure on Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Achieved Acute Procedural Success	Number of participants who achieved acute procedural success were reported. Acute procedural success was defined as confirmation of entrance block in all clinically relevant targeted pulmonary veins (PVs) after adenosine/ isoproterenol challenge.	Day 0 (Day of procedure)
Kaplan-Meier Estimates of the Success Rate of Freedom From Documented Symptomatic Re-Occurrence of Atrial Arrhythmia (Atrial Fibrillation [AF], Atrial Tachycardia [AT], or Atrial Flutter [AFL]) Episodes From Day 91 to Day 365 Post Index Procedure	Kaplan-Meier estimates of the success rate of freedom from primary effectiveness failure, that is, documented symptomatic re-occurrence of atrial arrhythmia (AF, AT, or AFL) episodes based on electrocardiographic data (>=30 seconds on arrhythmia monitoring device) from Day 91 to Day 365 post index procedure, was reported. Acute procedural failure defined as failure to confirm entrance block in all PVs except those that are silent and/or cannot be cannulated post-procedure, use of a non-study catheter for PV isolation, or failure to have PFA delivery with the study catheter due to IRE system malfunctions, was also considered a long-term effectiveness failure.	From Day 91 up to Day 365 post index procedure on Day 0
Change From Baseline in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score	Change from baseline in AFEQT total score was reported. The AFEQT questionnaire is an atrial fibrillation-specific health-related quality of life (HRQoL) questionnaire designed to assess the impact of atrial fibrillation on participants' HRQoL. The questionnaire includes 20 questions on a 7-point Likert scale. Questions 1-18 evaluate HRQoL and questions 19-20 relate to participants' satisfaction with treatment. Overall or subscale scores range from 0 to 100, where 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered). Therefore, a positive change in score corresponds to improvement in QoL. Total score was calculated using AFEQT formula: 100 -([sum of severity for all questions answered - number of questions answered]*100 / total number questions answered*6).	Baseline, Months 3, 6, and 12

Collaborators and Investigators

• Sponsor: Biosense Webster, Inc.

Publications and helpful links

General Publications

• Maheu-Cadotte MA, Dube V, Lavoie P. Development and Contribution of a Serious Game to Improve Nursing Students' Clinical Reasoning in Acute Heart Failure: A Multimethod Study. Comput Inform Nurs. 2022 Dec 1. doi: 10.1097/CIN.0000000000000966. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2020
• Primary Completion (Actual): May 9, 2023
• Study Completion (Actual): May 9, 2023

Study Registration Dates

• First Submitted: August 18, 2020
• First Submitted That Met QC Criteria: August 21, 2020
• First Posted (Actual): August 24, 2020

Study Record Updates

• Last Update Posted (Actual): May 25, 2025
• Last Update Submitted That Met QC Criteria: May 22, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: BWI_2019_08 (Other Identifier: Biosense Webster, Inc.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes