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

Completed · Not applicable

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT05293639

Run by

Biosense Webster, Inc.

People needed

362

Starts

2022-04-18

Expected to finish

2023-12-11

Last updated by the study team

2025-05-25

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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