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

Biosense Webster

Status: Enrolling

Conditions: Atrial Fibrillation

Treatments: Device: OMNYPULSE™ Catheter with the TRUPULSE Generator

Study type: Interventional

Funder types: Industry

Identifiers

NCT06455098

BWI202303

Details and patient eligibility

About

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.

Enrollment: 440 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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440 participants in 1 patient group

Pulsed Field (PF) Ablation System

Experimental group

Description:

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.

Treatment:

Device: OMNYPULSE™ Catheter with the TRUPULSE Generator