Clinical trial NCT06455098: A Study of Assessment on Safety and Effectiveness of BWI Pulsed Field Ablation With OMNYPULSE Catheter for the Treatment of Paroxysmal Atrial Fibrillation (PAF)
Official title: Assessment of Safety and Effectiveness in Treatment Management of Paroxysmal Atrial Fibrillation With the BWI Pulsed Field Ablation System With OMNYPULSE™ Catheter
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Biosense Webster, Inc.
Sponsor class: INDUSTRY
First posted: 2024-06-12
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Number of Participants with Primary Adverse Events (PAEs)
timeFrame: 7 days post-procedure
measure: 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
timeFrame: Day 91 to Day 365 post-procedure
Secondary outcomes:
measure: Change from Baseline in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score
timeFrame: Baseline, Month 12
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Cardiovascular Research Group
state: Arizona
city: Burlingame
country: United States
facility: Mills Peninsula Health Services
state: California
city: La Jolla
country: United States
facility: Scripps Clinic/Prebys Cardiovascular Institute
state: California
city: Larkspur
country: United States
facility: Cardiovascular Associates of Marin
state: California
city: Loma Linda
country: United States
facility: Loma Linda Medical Center
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital
state: California
city: San Diego
country: United States
facility: San Diego Cardiac Center
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center- Sutter Health
state: California
city: Santa Monica
country: United States
facility: Providence Saint John s Health Center
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Jacksonville
country: United States
facility: Ascension St. Vincent's
state: Florida
city: Jacksonville
country: United States
facility: Baptist Health Research Institute
state: Florida
city: Miami
country: United States
facility: HCA Florida Mercy Hospital
state: Florida
city: Naples
country: United States
facility: NCH Healthcare
state: Florida
city: Orlando
country: United States
facility: Advent Health Orlando
state: Florida
city: Atlanta
country: United States
facility: Piedmont Healthcare
state: Georgia
city: Atlanta
country: United States
facility: Emory Saint Joseph's Hospital
state: Georgia
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
city: Savannah
country: United States
facility: Memorial Health University Medical Center
state: Georgia
city: Glenview
country: United States
facility: NorthShore University Medical Center
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: Massachusetts General
state: Massachusetts
city: Boston
country: United States
facility: Brigham And Women's Hospital
state: Massachusetts
city: Royal Oak
country: United States
facility: Beaumont Health Systems
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute
state: Minnesota
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Heart Institute
state: New Mexico
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: New York
country: United States
facility: New York Presbyterian - Weill Cornell Medical Ctr
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Roslyn
country: United States
facility: St Francis Hospital
state: New York
city: Raleigh
country: United States
facility: WakeMed Heart & Vascular
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
city: York
country: United States
facility: York Hospital
state: Pennsylvania
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research Foundation
state: Texas
city: Houston
country: United States
facility: Texas Heart Institute
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Falls Church
country: United States
facility: Inova Fairfax Medical Campus- Inova Heart and Vascular Institute
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
city: Garran
country: Australia
facility: Canberra Heart Rhythm
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
Study officials:
affiliation: Biosense Webster, Inc.
name: Biosense Webster, Inc. Clinical Trial
role: STUDY_DIRECTOR
References: