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

NCT ID: NCT05293639

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 362 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-18
• Study Completion Date: 2023-12-11

Brief Summary

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.

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Group

PFA ablation using a circular multi-electrode pulsed electrical field catheter and multichannel generator

Group Type: EXPERIMENTAL

Pulse Field Ablation

Intervention Type: DEVICE

PFA ablation using a circular multi-electrode pulsed electrical field catheter and multichannel generator

Interventions

Pulse Field Ablation

PFA ablation using a circular multi-electrode pulsed electrical field catheter and multichannel generator

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biosense Webster, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Biosense Webster Inc. Clinical Trial

Role: STUDY_DIRECTOR

Biosense Webster, Inc.

Locations

Grandview Medical Center

Birmingham, Alabama, United States

Phoenix Cardiovascular Research

Phoenix, Arizona, United States

Arrhythmia Research Group (St. Bernards)

Jonesboro, Arkansas, United States

Cardiovascular Group of Marin/SF Med Group

Larkspur, California, United States

Hoag Memorial Hospital

Newport Beach, California, United States

San Diego Cardiac Center

San Diego, California, United States

Medstar Washington Hospital Center

Washington D.C., District of Columbia, United States

Florida Hospital

Orlando, Florida, United States

Piedmont Healthcare

Atlanta, Georgia, United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Memorial Health University Medical Center

Savannah, Georgia, United States

Evanston Hospital / Northshore

Evanston, Illinois, United States

Johns Hopkins

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Minneapolis Heart Institute

Minneapolis, Minnesota, United States

Morristown Medical Center

Morristown, New Jersey, United States

South Shore University Hospital

Bay Shore, New York, United States

New York University Langone Med Center

New York, New York, United States

New York Presbyterian Hospital

New York, New York, United States

Mount Sinai School of Medicine

New York, New York, United States

Albert Einstein College of Medicine

The Bronx, New York, United States

Wakemed Heart and Vascular

Raleigh, North Carolina, United States

Wake Forest Baptist Health

Winston-Salem, North Carolina, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, United States

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, United States

Baylor Research Institute

Plano, Texas, United States

Inova Fairfax Medical Center

Falls Church, Virginia, United States

Virginia Commonwealth Uninversity

Richmond, Virginia, United States

Countries

United States

References

Di Biase L, Reddy VY, Bahu M, Newton D, Liu CF, Sauer WH, Goyal S, Iyer V, Nair D, Osorio J, Mansour M, Calkins H, Wazni O, Natale A. Early versus late atrial fibrillation recurrence after pulsed field ablation: insights from the admIRE trial. Europace. 2025 Feb 5;27(2):euaf007. doi: 10.1093/europace/euaf007.

Reference Type: DERIVED

PMID: 39820338 (View on PubMed)

Reddy VY, Calkins H, Mansour M, Wazni O, Di Biase L, Bahu M, Newton D, Liu CF, Sauer WH, Goyal S, Iyer V, Nair D, Athill C, Hussein A, Whalen P, Melby D, Natale A; AdmIRE Trial Investigators. Pulsed Field Ablation to Treat Paroxysmal Atrial Fibrillation: Safety and Effectiveness in the AdmIRE Pivotal Trial. Circulation. 2024 Oct 8;150(15):1174-1186. doi: 10.1161/CIRCULATIONAHA.124.070333. Epub 2024 Sep 11.

Reference Type: DERIVED

PMID: 39258362 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

BWI201910

Identifier Type: -

Identifier Source: org_study_id