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

NCT04524364 | Completed Results DMC FDA Device

• 1 other identifier: BWI_2019_08
• Study Type: interventional
• Target: 272
• Locations: 8 countries
• Sites: 13

Brief Summary

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).

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Number of Participants Who Achieved Acute Procedural Success

  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

  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

  Baseline, Months 3, 6, and 12

Study Arms (1)

Participants with Paroxysmal Atrial Fibrillation (PAF)

OTHER

Participants with PAF and who are candidates for catheter ablation will be enrolled.

Device: Pulsed Field Ablation (PFA) Therapy

Interventions

Pulsed Field Ablation (PFA) Therapy DEVICE

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).

Participants with Paroxysmal Atrial Fibrillation (PAF)

Eligibility Criteria

• Age: 18 Years - 75 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)
• 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

You may not qualify if:

• 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))

Sponsors & Collaborators

• Biosense Webster, Inc.: lead

Study Sites (13)

Medical University Graz

Graz, 8036, Austria

Location

Ordensklinikum Linz Elisabethinen

Linz, 4020, Austria

Location

OLV Aalst

Aalst, 9300, Belgium

Location

AZ Sint-Jan Brugge

Bruges, 8000, Belgium

Location

Ziekenhuis Oost-Limburg Genk Campus Sint-Jan

Genk, 3600, Belgium

Location

Jessa Ziekenhuis - Campus Virga Jesse

Hasselt, 3500, Belgium

Location

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

Southlake Regional Health Centre

Newmarket, ON L3Y 2P9, Canada

Location

University Hospital Center Split

Split, 21000, Croatia

Location

Nemocnice na Homolce

Prague, 150 30 District 5, Czechia

Location

Centre Hospitalier Universitaire (CHU) de Bordeaux

Bordeaux, 33600, France

Location

Ospedale Generale Regionale "F. Miulli"

Acquaviva delle Fonti, 70021, Italy

Location

Vilnius University Hospital

Vilnius, 8661, Lithuania

Location

Related Publications (2)

• De Potter T, Grimaldi M, Duytschaever M, Anic A, Vijgen J, Neuzil P, Van Herendael H, Verma A, Skanes A, Scherr D, Purerfellner H, Rackauskas G, Jais P, Reddy VY; inspIRE Trial Investigators. Predictors of Success for Pulmonary Vein Isolation With Pulsed-field Ablation Using a Variable-loop Catheter With 3D Mapping Integration: Complete 12-month Outcomes From inspIRE. Circ Arrhythm Electrophysiol. 2024 May;17(5):e012667. doi: 10.1161/CIRCEP.123.012667. Epub 2024 Apr 24.

  PMID: 38655693 DERIVED

• Duytschaever M, De Potter T, Grimaldi M, Anic A, Vijgen J, Neuzil P, Van Herendael H, Verma A, Skanes A, Scherr D, Purerfellner H, Rackauskas G, Jais P, Reddy VY; inspIRE Trial Investigators. Paroxysmal Atrial Fibrillation Ablation Using a Novel Variable-Loop Biphasic Pulsed Field Ablation Catheter Integrated With a 3-Dimensional Mapping System: 1-Year Outcomes of the Multicenter inspIRE Study. Circ Arrhythm Electrophysiol. 2023 Mar;16(3):e011780. doi: 10.1161/CIRCEP.122.011780. Epub 2023 Feb 3.

  PMID: 36735937 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Associate Director - Medical Affairs
• Organization: Biosense Webster, Inc.

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

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: August 18, 2020
• First Posted: August 24, 2020
• Study Start: August 23, 2020
• Primary Completion: May 9, 2023
• Study Completion: May 9, 2023
• Last Updated: May 25, 2025
• Results First Posted: May 14, 2024

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

IT (1); CZ (1); LI (1); BE (4); CR (1); CA (2); AU (2); FR (1)