Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the BWI IRE Ablation System (AdmIRE)

May 22, 2025 updated by: Biosense Webster, Inc.

Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the BWI IRE Ablation System (AdmIRE)

To demonstrate the safety and 12-month effectiveness of the VARIPULSE™ Catheter when used in conjunction with the TRUPULSE™ Generator for pulmonary vein isolation (PVI) in the treatment of subjects with symptomatic paroxysmal atrial fibrillation.

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.

Detailed Description

This is a prospective, non-randomized, multi-center, clinical evaluation of the Biosense Webster IRE Ablation system to demonstrate safety and long-term effectiveness for the treatment of drug refractory symptomatic PAF. The BWI IRE Ablation System consists of the VARIPULSE™ Catheter and TRUPULSE™ Generator. In conjunction with CARTO™ 3 system, it is indicated for PVI of patients with drug refractory paroxysmal atrial fibrillation.

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.
362

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

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35243
        • Grandview Medical Center
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Phoenix Cardiovascular Research
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Arrhythmia Research Group (St. Bernards)
    • California
      • Larkspur, California, United States, 94904
        • Cardiovascular Group of Marin/SF Med Group
      • Newport Beach, California, United States, 92663
        • Hoag Memorial Hospital
      • San Diego, California, United States, 92123
        • San Diego Cardiac Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • MedStar Washington Hospital Center
    • Florida
      • Orlando, Florida, United States, 32803
        • Florida Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Emory Saint Joseph's Hospital
      • Atlanta, Georgia, United States, 30309
        • Piedmont Healthcare
      • Savannah, Georgia, United States, 31404
        • Memorial Health University Medical Center
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Evanston Hospital / Northshore
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Johns Hopkins
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55414
        • Minneapolis Heart Institute
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Morristown Medical Center
    • New York
      • Bay Shore, New York, United States, 11706
        • South Shore University Hospital
      • Bronx, New York, United States, 10561
        • Albert Einstein College of Medicine
      • New York, New York, United States, 10021
        • New York Presbyterian Hospital
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine
      • New York, New York, United States, 10016
        • New York University Langone Med Center
    • North Carolina
      • Raleigh, North Carolina, United States, 27610
        • Wakemed Heart and Vascular
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Health
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Penn Presbyterian Medical Center
    • Texas
      • Austin, Texas, United States, 78705
        • Texas Cardiac Arrhythmia Research Foundation
      • Plano, Texas, United States, 75093
        • Baylor Research Institute
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Medical Center
      • Richmond, Virginia, United States, 23285
        • Virginia Commonwealth Uninversity

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

Key Inclusion Criteria:

  • Diagnosed with Symptomatic Paroxysmal Atrial Fibrillation with

    1. At least two symptomatic AF episodes within last six months from enrollment.
    2. At least one ectrocardiographically documented AF episode within twelve (12) months prior to enrollment.
  • Failed at least one Class I or Class III antiarrhythmic drug.

Exclusion Criteria:

  • Previously diagnosed with persistent AF (> 7 days in duration).
  • AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
  • Previous surgical or catheter ablation for AF.
  • Patients known to require ablation outside the PV region
  • Documented severe dilatation of the LA (LAD >50mm) antero-posterior diameter on imaging within 6 months prior to enrollment.
  • Documented LA thrombus by imaging within 48 hours of the procedure.
  • Documented severely compromised LVEF (<40%) by imaging within 6 months prior to enrollment
  • Uncontrolled heart failure or New York Heart Association Class III or IV
  • History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran),
  • Documented thromboembolic event (including TIA) within the past 12 months
  • Previous PCI/MI within the past 2 months
  • Coronary Artery Bypass Grafting (CABG) surgery within the past 6 months (180 days)
  • Valvular cardiac surgical/percutaneous procedure
  • Unstable angina within 6 months
  • Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months.
  • Significant pulmonary disease or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms.
  • Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
  • Prior diagnosis of pulmonary vein stenosis
  • Pre-existing hemi diaphragmatic paralysis
  • Acute illness, active systemic infection, or sepsis
  • Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation.
  • Severe mitral regurgitation
  • Presence of implanted pacemaker or Implantable Cardioverter-Defibrillator (ICD) or other implanted metal cardiac device that may interfere with the IRE energy field.
  • Presence of a condition that precludes vascular access
  • Current enrollment in an investigational study evaluating another device or drug.
  • Women who are pregnant, lactating, or who are of child-bearing age and plan on becoming pregnant during the course of the clinical investigation.
  • Life expectancy less than 12 months

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.
Experimental: Treatment Group
PFA ablation using a circular multi-electrode pulsed electrical field catheter and multichannel generator
Device: Pulse Field Ablation
PFA ablation using a circular multi-electrode pulsed electrical field catheter and multichannel generator

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
Pivotal Main Phase Modified Intent-To-Treat (mITT) Analysis Set: Number of Participants With Primary Adverse Events (PAEs)
Time Frame: From Day 0 to Day 7 post catheter insertion on Day 0
An adverse event (AE) was 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. PAEs included the following AEs: Phrenic Nerve Paralysis (permanent), Stroke/Cerebrovascular accident (CVA), Major Vascular Access Complication/Bleeding, Thromboembolism, Myocardial Infarction, Transient Ischemic Attack (TIA), Pericarditis, Pulmonary Edema (Respiratory Insufficiency), Heart Block, and Vagal Nerve Injury/ Gastroparesis.
From Day 0 to Day 7 post catheter insertion on Day 0
Pilot Safety Analysis Set and Pivotal Roll-In Analysis Set: Number of Participants With Primary Adverse Events (PAEs)
Time Frame: From Day 0 to Day 7 post catheter insertion 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. PAEs included the following AEs: Phrenic Nerve Paralysis (permanent), Stroke/CVA, Major Vascular Access Complication/Bleeding, Thromboembolism, Myocardial Infarction, Transient Ischemic Attack (TIA), Pericarditis, Pulmonary Edema (Respiratory Insufficiency), Heart Block, and Vagal Nerve Injury/ Gastroparesis.
From Day 0 to Day 7 post catheter insertion on Day 0
Pivotal Main Phase Per-Protocol (PP) Analysis Set: Number of Participants With Freedom of Documented Atrial Tachyarrhythmia
Time Frame: Day 91 to Day 365 post catheter insertion on Day 0
Number of Participants With freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmia (atrial fibrillation [AF], atrial tachycardia [AT], or atrial flutter [AFL] of unknown origin positive) episodes based on electrocardiographic data (greater than or equal to [>=] 30 seconds on an electrocardiogram [ECG], sponsor-provided cardiac event monitor [CEM], or Holter device) during the effectiveness evaluation period (Day 91-365 post catheter insertion procedure) and freedom from the following failure modes: acute procedural failure, repeat ablation failure, non-study catheter failure, AAD failure, continuous AF/AT/AFL of unknown origin on ECG, any Direct Current Cardioversion (DCCV) procedure were reported.
Day 91 to Day 365 post catheter insertion on Day 0
Pilot Safety Analysis Set and Pivotal Roll-In Analysis Set: Number of Participants With Freedom of Documented Atrial Tachyarrhythmia
Time Frame: Day 91 to Day 365 post catheter insertion on Day 0
Number of Participants With freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmia (AF, AT, or AFL of unknown origin positive) episodes based on electrocardiographic data (>=30 seconds on an ECG, CEM, or Holter device) during the effectiveness evaluation period (Day 91-365 post catheter insertion) and freedom from the following failure modes: acute procedural failure, repeat ablation failure, non-study catheter failure, AAD failure, continuous AF/AT/AFL of unknown origin on ECG, any DCCV procedure were reported.
Day 91 to Day 365 post catheter insertion 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
Pivotal Main Phase PP Analysis Set: Change From Baseline in Overall Atrial Fibrillation Effect on Quality-of-Life Questionnaire (AFEQT) Total Score
Time Frame: Baseline, and 12 months post catheter insertion on Day 0
Change from baseline in overall AFEQT total score were reported. Change in the AFEQT score included 20 questions on a 7-point Likert scale. Questions 1-18 evaluated Health Related Quality of Life (HRQoL) and questions 19-20 were related to the patient's satisfaction with treatment. The first 18 questions were used to calculate the overall AFEQT score. The total AFEQT scores was calculated as 100 minus ([Sum of severity for all questions answered minus number of questions answered) divided by total number of questions answered*6])*100. The overall AFEQT scores ranged from 0 (complete disability) to 100 (no disability). Therefore, a positive change in score corresponded to improvement in QoL.
Baseline, and 12 months post catheter insertion on Day 0
Pilot Safety Analysis Set and Pivotal Roll-In Analysis Set: Change From Baseline in Overall Atrial Fibrillation Effect on Quality-of-Life Questionnaire (AFEQT) Total Score
Time Frame: Baseline, and 12 months post catheter insertion on Day 0
Change from baseline in overall AFEQT total score were reported. Change in the AFEQT score included 20 questions on a 7-point Likert scale. Questions 1-18 evaluated HRQoL and questions 19-20 were related to the patient's satisfaction with treatment. The first 18 questions were used to calculate the overall AFEQT score. The total AFEQT scores was calculated as 100 minus ([Sum of severity for all questions answered minus number of questions answered) divided by total number of questions answered*6])*100. The overall AFEQT scores ranged from 0 (complete disability) to 100 (no disability). Therefore, a positive change in score corresponded to improvement in QoL.
Baseline, and 12 months post catheter insertion on Day 0

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.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Biosense Webster Inc. Clinical Trial, Biosense Webster, Inc.

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.
April 18, 2022

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.
December 11, 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.
December 11, 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).
March 15, 2022

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.
March 15, 2022

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.
March 24, 2022

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

Keywords

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.
  • BWI201910

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Johnson & Johnson Medical Devices 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.

No

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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