RECRUITINGINTERVENTIONAL
A Study of Assessment on Safety and Effectiveness of BWI Pulsed Field Ablation With OMNYPULSE Catheter for the Treatment of Paroxysmal Atrial Fibrillation (PAF)
Assessment of Safety and Effectiveness in Treatment Management of Paroxysmal Atrial Fibrillation With the BWI Pulsed Field Ablation System With OMNYPULSE™ Catheter
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- Diagnosed with symptomatic paroxysmal AF with:
1. At least two symptomatic AF episodes within last six months from enrollment
2. 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
Who Should NOT Join This Trial:
- 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
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Diagnosed with symptomatic paroxysmal AF with:
1. At least two symptomatic AF episodes within last six months from enrollment
2. 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
Exclusion Criteria:
* 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)
Treatments Being Tested
DEVICE
OMNYPULSE™ Catheter with the TRUPULSE Generator
OMNYPULSE™ Catheter and TRUPULSE™ Generator will be used for PF ablation.
Locations (20)
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
Northside Hospital
Atlanta, Georgia, United States
Memorial Health University Medical Center
Savannah, Georgia, United States