RECRUITING

A Study of Assessment on Safety and Effectiveness of BWI Pulsed Field Ablation With OMNYPULSE Catheter for the Treatment of Paroxysmal Atrial Fibrillation (PAF)

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Conditions

Atrial Fibrillation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to demonstrate the safety and 12-month effectiveness of the BWI OMNYPULSE™ pulsed field ablation (PFA) platform for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF), an irregular heart rate that causes abnormal blood flow.

Official Title

Assessment of Safety and Effectiveness in Treatment Management of Paroxysmal Atrial Fibrillation With the BWI Pulsed Field Ablation System With OMNYPULSE™ Catheter

Quick Facts

Study Start:2024-06-28
Study Completion:2026-05-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06455098

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.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosed with symptomatic paroxysmal AF with:
  2. 1. At least two symptomatic AF episodes within last six months from enrollment
  3. 2. At least one electrocardiographically documented AF episode within twelve months prior to enrollment
  4. * Failed at least one Class I or Class III antiarrhythmic drug
  5. * Willing and capable to provide consent
  6. * Able and willing to comply with all pre-, post- and follow-up testing and requirements
  1. * Previously diagnosed with persistent AF (greater than \[\>\] 7 days in duration)
  2. * AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
  3. * Previous surgical or catheter ablation for AF
  4. * Patients known to require ablation outside the PV ostia and outside the CTI region.
  5. * Documented severe dilatation of the left atrium (LAD\>50 mm) antero-posterior diameter on imaging within 6 months prior to enrollment
  6. * Documented left atrium (LA) thrombus by imaging within 48 hours of the procedure
  7. * Documented severely compromised left ventricular ejection fraction (LVEF \<40%) by imaging within 6 months prior to enrollment
  8. * Uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV
  9. * History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran)
  10. * Documented thromboembolic event (including transient ischemic attack or TIA) within the past 6 months
  11. * Previous Percutaneous Coronary Intervention (PCI)/ myocardial infarction \[MI\] within the past 2 months
  12. * Coronary Artery Bypass Grafting (CABG) surgery within the past 6 months
  13. * Valvular cardiac surgical/percutaneous procedure
  14. * Unstable angina within 6 months
  15. * Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months
  16. * Significant pulmonary disease or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms
  17. * Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
  18. * Prior diagnosis of pulmonary vein stenosis
  19. * Pre-existing hemi diaphragmatic paralysis
  20. * Acute illness, active systemic infection, or sepsis
  21. * Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation
  22. * Severe mitral regurgitation
  23. * Presence of an implanted pacemaker or Implantable Cardioverter-Defibrillator (ICD) or other implanted metal cardiac device (other than coronary stents) that may interfere with the PF energy field)
  24. * Presence of a condition that precludes vascular access
  25. * Current enrollment in an investigational study evaluating another device or drug
  26. * Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of child-bearing age and plan on becoming pregnant during the course of the clinical investigation
  27. * Life expectancy less than 12 months
  28. * Presenting contra-indications for the devices used in the study, as indicated in the respective Instructions for Use (IFU)

Contacts and Locations

Study Contact

Study Contact
CONTACT
949-789-3919
rshar120@its.jnj.com

Principal Investigator

Biosense Webster, Inc. Clinical Trial
STUDY_DIRECTOR
Biosense Webster, Inc.

Study Locations (Sites)

Phoenix Cardiovascular Research Group
Phoenix, Arizona, 85018
United States
Mills Peninsula Health Services
Burlingame, California, 94010
United States
Cardiovascular Associates of Marin
Larkspur, California, 94939
United States
Loma Linda Medical Center
Loma Linda, California, 92354
United States
Hoag Memorial Hospital
Newport Beach, California, 92663
United States
San Diego Cardiac Center
San Diego, California, 92123
United States
California Pacific Medical Center- Sutter Health
San Francisco, California, 94109
United States
Providence Saint John s Health Center
Santa Monica, California, 90404
United States
University of Colorado
Aurora, Colorado, 80045
United States
Hartford Hospital
Hartford, Connecticut, 06102
United States
Ascension St. Vincent's
Jacksonville, Florida, 32204
United States
Baptist Health Research Institute
Jacksonville, Florida, 32207
United States
HCA Florida Mercy Hospital
Miami, Florida, 33133
United States
NCH Healthcare
Naples, Florida, 34102
United States
Advent Health Orlando
Orlando, Florida, 32803
United States
Piedmont Healthcare
Atlanta, Georgia, 30309
United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
United States
Northside Hospital
Atlanta, Georgia, 30342
United States
Memorial Health University Medical Center
Savannah, Georgia, 31404
United States
NorthShore University Medical Center
Evanston, Illinois, 60201
United States
Johns Hopkins
Baltimore, Maryland, 21287
United States
Massachusetts General
Boston, Massachusetts, 02114
United States
Brigham And Women's Hospital
Boston, Massachusetts, 02115
United States
Beaumont Health Systems
Royal Oak, Michigan, 48073
United States
Minneapolis Heart Institute
Minneapolis, Minnesota, 55414
United States
Morristown Medical Center
Morristown, New Jersey, 07960
United States
New Mexico Heart Institute
Albuquerque, New Mexico, 87102
United States
Montefiore Medical Center
Bronx, New York, 10467
United States
Mount Sinai School of Medicine
New York, New York, 10029
United States
New York Presbyterian - Weill Cornell Medical Ctr
New York, New York, 10065
United States
Lenox Hill Hospital
New York, New York, 10075
United States
St Francis Hospital
Roslyn, New York, 11576
United States
WakeMed Heart & Vascular
Raleigh, North Carolina, 27610
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
United States
York Hospital
York, Pennsylvania, 17403
United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705
United States
Texas Heart Institute
Houston, Texas, 77030
United States
Intermountain Medical Center
Murray, Utah, 84107
United States
Inova Fairfax Medical Campus- Inova Heart and Vascular Institute
Falls Church, Virginia, 22042
United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
United States
Virginia Commonwealth University
Richmond, Virginia, 23298
United States

Collaborators and Investigators

Sponsor: Biosense Webster, Inc.

  • Biosense Webster, Inc. Clinical Trial, STUDY_DIRECTOR, 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 Registration Dates

Study Start Date2024-06-28
Study Completion Date2026-05-30

Study Record Updates

Study Start Date2024-06-28
Study Completion Date2026-05-30

Terms related to this study

Additional Relevant MeSH Terms

  • Atrial Fibrillation