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

June 28, 2023 updated by: Biosense Webster, Inc.

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

272

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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 of Primary Adverse Events (PAEs)
Time Frame: Within one week (7 days) post-procedure
Participants with incidence of Primary Adverse Events (PAEs) (within seven (7) days of the initial mapping and ablation procedure) will be reported. PAEs include the adverse events like Atrio-esophageal fistula, cardiac tamponade/perforation, device or procedure related death, major vascular access complication/bleeding, myocardial infarction and pericarditis, phrenic nerve paralysis (permanent), pulmonary vein stenosis, stroke/CVA, thromboembolism, transient Ischemic Attack (TIA)
Within one week (7 days) post-procedure
Rate of Freedom from Documented (Symptomatic and Asymptomatic) Atrial Arrhythmia (Atrial Fibrillation [AF], Atrial Tachycardia [AT], or Atrial Flutter [AFL] Greater than Equal to (>=)30 Seconds Within 91-365 days post Index Procedure
Time Frame: 91-365 Days
Atrial arrhythmia recurrence events will be recorded and included as a study endpoint after a 90-day blanking period; recurrence during the blanking will not be considered treatment failure. In addition, re-ablation will not be recommended during the blanking period.
91-365 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants who Achieved Acute Procedural Success
Time Frame: 91-365 Days
Acute procedural success defined as confirmation of entrance block in all clinically relevant targeted PVs after adenosine/ isoproterenol challenge.
91-365 Days
Rate of Freedom from Documented Symptomatic Re-Occurrence Atrial Arrhythmia (Atrial Fibrillation [AF], Atrial Tachycardia [AT], or Atrial Flutter [AFL]) >=30 Seconds Within 91-365 days post Index Procedure
Time Frame: 91-365 Days
Atrial arrhythmia recurrence events will be recorded and included as a study endpoint after a 90-day blanking period; recurrence during the blanking will not be considered treatment failure. In addition, re-ablation will not be recommended during the blanking period.
91-365 Days
Change from Baseline in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score
Time Frame: Baseline, Month 3, 6 and 12
An overall AFEQT score ranges from 0 to 100. A score of 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 AF symptoms.
Baseline, Month 3, 6 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biosense Webster, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)

June 29, 2023

Last Update Submitted That Met QC Criteria

June 28, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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