Safety and Effectiveness Evaluation of the OMNYPULSE* Catheter with the TRUPULSE* generator for treatment of Paroxysmal Atrial Fibrillation (PAF)

• Conditions: arrhythmia - cardiac rhythm disorder; 10007521

• Registration Number: NL-OMON56476
• Lead Sponsor: Biosense Webster Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

1. Diagnosed with Symptomatic Paroxysmal AF defined as AF that terminates
spontaneously or with intervention within 7 days of onset. This PAF is
considered to be symptomatic if symptoms related to AF are experienced by the
patient.
2. Selected for AF ablation procedure by pulmonary vein isolation (PVI).
3. Age 18-75 years.
4. Willing and capable of providing consent.
5. Able and willing to comply with all pre-, post- and follow-up testing and
requirements.

Exclusion Criteria

1. Previously known AF secondary to electrolyte imbalance, thyroid disease, or
reversible or non-cardiac cause (e.g., documented obstructive sleep apnea,
acute alcohol toxicity, morbid obesity (Body Mass Index >40 kg/m²), renal
insufficiency (with an estimated creatinine clearance < 30 mL/min/1.73 m2) *.).
2. Previous LA ablation or surgery. 3. Patients known to require ablation
outside the PV region (e.g., atrioventricular reentrant tachycardia,
atrioventricular nodal re-entry tachycardia, atrial tachycardia, ventricular
tachycardia and Wolff-Parkinson-White). 4. Previously diagnosed with persistent
AF (> 7 days in duration). 5. Severe dilatation of the LA (LAD >50mm
antero-posterior diameter in case of Transthoracic Echocardiography (TTE)). 6.
Presence of LA thrombus. 7. Severely compromised Left Ventricular Ejection
Fraction (LVEF <40%). 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. History of a documented thromboembolic event (including TIA)
within the past 6 months. 11. Previous Percutaneous Coronary Intervention (PCI)
/ Myocardial Infarction (MI) within the past 2 months. 12. Previous Coronary
Artery Bypass Grafting (CABG) in conjunction with valvular surgery, cardiac
surgery (e.g., ventriculotomy, atriotomy) or valvular cardiac (surgical or
percutaneous) procedure. 13. Unstable angina pectoris within the past 6 months.
14. Anticipated cardiac transplantation, cardiac surgery, or other major
surgery within the next 12 months. 15. Significant pulmonary disease (e.g.,
restrictive pulmonary disease, constrictive or chronic obstructive pulmonary
disease) or any other disease or malfunction of the lungs or respiratory system
that produces severe chronic symptoms. 16. Known significant PV anomaly that in
the opinion of the investigator would preclude enrollment in this study. 17.
Prior diagnosis of pulmonary vein stenosis. 18. Pre-existing hemi diaphragmatic
paralysis. 19. Acute illness, active systemic infection, or sepsis. 20.
Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch
or other abnormality that precludes catheter introduction or manipulation. 21.
Severe mitral regurgitation. 22. Presence of implanted pacemaker or Implantable
Cardioverter-Defibrillator (ICD) or other implanted metal cardiac device that
may interfere with the pulsed electric field energy. 23. Presence of a
condition that precludes vascular access (such as Inferior Vena Cava (IVC)
filter) 24. Significant congenital anomaly or a medical problem that in the
opinion of the investigator would preclude enrollment in this study. 25.
Categorized as vulnerable population and requires special treatment with
respect to safeguards of well-being. 26. Current enrollment in an
investigational study evaluating another device or drug. 27. 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. 28. Life expectancy less than 12 months. 29. Presenting
contra-indications for the devices used in the study, as indicated in the
respective Instructions For Use (IFU). Additional exclu

Study & Design

• Study Type: Interventional
• Study Design: Not specified