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

May 22, 2025 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
272

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Primary Adverse Events (PAEs)
Time Frame: Within 7 days post-procedure on Day 0
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
Time Frame: From Day 91 up to Day 365 post index procedure on Day 0
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants Who Achieved Acute Procedural Success
Time Frame: Day 0 (Day of procedure)
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
Time Frame: From Day 91 up to Day 365 post index procedure on Day 0
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
Time Frame: Baseline, Months 3, 6, and 12
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

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 23, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 9, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 9, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 18, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 24, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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