A Study of Assessment on Safety and Effectiveness of BWI Pulsed Field Ablation With OMNYPULSE Catheter for the Treatment of Paroxysmal Atrial Fibrillation (PAF)
- Conditions
- Atrial Fibrillation
- Interventions
- Device: OMNYPULSE™ Catheter with the TRUPULSE Generator
- Registration Number
- NCT06455098
- Lead Sponsor
- Biosense Webster, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 440
-
Diagnosed with symptomatic paroxysmal AF with:
- At least two symptomatic AF episodes within last six months from enrollment
- At least one electrocardiographically documented AF episode within twelve months prior to enrollment
-
Failed at least one Class I or Class III antiarrhythmic drug
-
Willing and capable to provide consent
-
Able and willing to comply with all pre-, post- and follow-up testing and requirements
- Previously diagnosed with persistent AF (greater than [>] 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 ostia and outside the CTI region.
- Documented severe dilatation of the left atrium (LAD>50 mm) antero-posterior diameter on imaging within 6 months prior to enrollment
- Documented left atrium (LA) thrombus by imaging within 48 hours of the procedure
- Documented severely compromised left ventricular ejection fraction (LVEF <40%) by imaging within 6 months prior to enrollment
- Uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV
- History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran)
- Documented thromboembolic event (including transient ischemic attack or TIA) within the past 6 months
- Previous Percutaneous Coronary Intervention (PCI)/ myocardial infarction [MI] within the past 2 months
- Coronary Artery Bypass Grafting (CABG) surgery within the past 6 months
- 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 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)
- Presence of a condition that precludes vascular access
- Current enrollment in an investigational study evaluating another device or drug
- 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
- Life expectancy less than 12 months
- Presenting contra-indications for the devices used in the study, as indicated in the respective Instructions for Use (IFU)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pulsed Field (PF) Ablation System OMNYPULSE™ Catheter with the TRUPULSE Generator Participants with PAF will undergo pulsed field ablation procedure with the OMNYPULSE™ catheter in combination with TRUPULSE™ generator for PVI and to deliver pulsed field (PF) energy for treatment of atrial fibrillation. Study participants will be followed for 12 months after the study index procedure.
- Primary Outcome Measures
Name Time Method Number of Participants with Primary Adverse Events (PAEs) 7 days post-procedure Number of participants with PAEs (within 7 days following the ablation procedure unless otherwise indicated) will be reported. PAEs will include the following adverse events: esophageal perforating complications (atrio-esophageal fistula, esophago-pericardial fistula), phrenic nerve paralysis (permanent), cardiac tamponade/perforation, pulmonary vein stenosis (PVS), device or procedure related death, stroke/cerebrovascular accident (CVA), major vascular access complication/bleeding, thromboembolism, myocardial infarction, transient ischemic attack (TIA), pericarditis, heart block, pulmonary edema (respiratory insufficiency) and vagal nerve injury/gastroparesis.
Number of Participants Reporting Freedom from Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia (Atrial Fibrillation [AF], Atrial Tachycardia [AT] or Atrial Flutter [AFL] of Unknown Origin) Episodes Day 91 to Day 365 post-procedure Number of participants reporting freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmia (AF, AT, or AFL of unknown origin) episodes of \>= 30 seconds based on sponsor provided transtelephonic monitoring (TTM) or holter device or continuous on standard 12-lead electrocardiogram (ECG) data during the effectiveness evaluation period will be reported.
- Secondary Outcome Measures
Name Time Method Change from Baseline in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score Baseline, Month 12 The AFEQT uses a questionnaire to evaluate symptoms, daily activities and treatment concerns participants have related to atrial fibrillation. An overall AFEQT score ranges from 0 to 100. A score of 0 corresponds to complete disability (or responding "extremely" difficult 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). A positive change in score corresponds to improvement in AF symptoms.
Trial Locations
- Locations (46)
NorthShore University Medical Center
🇺🇸Glenview, Illinois, United States
Intermountain Medical Center
🇺🇸Murray, Utah, United States
Inova Fairfax Medical Campus- Inova Heart and Vascular Institute
🇺🇸Falls Church, Virginia, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
Royal Adelaide Hospital
🇦🇺Adelaide, Australia
Canberra Heart Rhythm
🇦🇺Garran, Australia
Royal Melbourne Hospital
🇦🇺Parkville, Australia
Northside Hospital
🇺🇸Atlanta, Georgia, United States
Memorial Health University Medical Center
🇺🇸Savannah, Georgia, United States
Phoenix Cardiovascular Research Group
🇺🇸Phoenix, Arizona, United States
Mills Peninsula Health Services
🇺🇸Burlingame, California, United States
Scripps Clinic/Prebys Cardiovascular Institute
🇺🇸La Jolla, California, United States
Cardiovascular Associates of Marin
🇺🇸Larkspur, California, United States
Loma Linda Medical Center
🇺🇸Loma Linda, California, United States
Hoag Memorial Hospital
🇺🇸Newport Beach, California, United States
San Diego Cardiac Center
🇺🇸San Diego, California, United States
California Pacific Medical Center- Sutter Health
🇺🇸San Francisco, California, United States
Providence Saint John s Health Center
🇺🇸Santa Monica, California, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Ascension St. Vincent's
🇺🇸Jacksonville, Florida, United States
Baptist Health Research Institute
🇺🇸Jacksonville, Florida, United States
HCA Florida Mercy Hospital
🇺🇸Miami, Florida, United States
NCH Healthcare
🇺🇸Naples, Florida, United States
Advent Health Orlando
🇺🇸Orlando, Florida, United States
Piedmont Healthcare
🇺🇸Atlanta, Georgia, United States
Emory Saint Joseph's Hospital
🇺🇸Atlanta, Georgia, United States
Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Massachusetts General
🇺🇸Boston, Massachusetts, United States
Brigham And Women's Hospital
🇺🇸Boston, Massachusetts, United States
Beaumont Health Systems
🇺🇸Royal Oak, Michigan, United States
Minneapolis Heart Institute
🇺🇸Minneapolis, Minnesota, United States
Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
New Mexico Heart Institute
🇺🇸Albuquerque, New Mexico, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
New York Presbyterian - Weill Cornell Medical Ctr
🇺🇸New York, New York, United States
Lenox Hill Hospital
🇺🇸New York, New York, United States
St Francis Hospital
🇺🇸Roslyn, New York, United States
WakeMed Heart & Vascular
🇺🇸Raleigh, North Carolina, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
University of Pennsylvania Health System
🇺🇸Philadelphia, Pennsylvania, United States
York Hospital
🇺🇸York, Pennsylvania, United States
Texas Cardiac Arrhythmia Research Foundation
🇺🇸Austin, Texas, United States
Texas Heart Institute
🇺🇸Houston, Texas, United States