arrhythmia - cardiac rhythm disorder
Conditions
Interventions
Subjects will arrive at the electrophysiology (EP) laboratory for their
ablation procedure and will undergo preparation for the procedure per the
hospital*s standard protocol (discretion of investig
Sponsors
Biosense Webster Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety The primary safety endpoint is the occurrence of Primary Adverse Events (PAEs) within seven (7) days of the index ablation procedure where the investigational OMNYPULSE* Bi-Directional Catheter and TRUPULSE* Generator are used per clinical investigation plan. PAEs include the following Adverse Events (AEs): Atrio-Esophageal Fistula* Phrenic Nerve Paralysis Cardiac Tamponade/perforation** Pulmonary Vein Stenosis* 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) Vagal Nerve Injury/Gastroparesis * Device or procedure related death, pulmonary vein stenosis and atrio-esophageal fistula that occur greater than one week (7 days) and less than or equal to 90 days post-procedure are considered and analyzed as PAEs. ** Cardiac Tamponade/Perforation occurring up to 30 days post AF ablation process procedure will be considered a PAE. Acute Effectiveness The acute effectiveness endpoint is the electrical isolation of clinically relevant targeted PVs which is evidenced by confirmation of entrance block after adenosine/isoproterenol challenge at the end of the index ablation procedure. Use of a non-study device to achieve PVI is considered an acute procedural failure. | — |
Secondary
| Measure | Time frame |
|---|---|
| 12-month Effectiveness Freedom from documented (symptomatic and asymptomatic) atrial arrhythmia (Atrial Fibrillation (AF), Atrial Tachycardia (AT) or Atrial Flutter (AFL) of unknown origin*) episodes based on electrocardiographic data (>=30 seconds on arrhythmia monitoring device) during the effectiveness evaluation period (day 91-day 365) on or off antiarrhythmic therapy. Acute procedural failure (i.e., failure to achieve entrance block with the study device in any of the clinically relevant targeted PVs) will also be deemed a 12- month effectiveness failure. *AFL of unknown origin is defined as all AFL except those CTI dependent AFL as confirmed by 12-lead electrocardiogram (ECG) or entrainment maneuvers in an EP study. | — |
Countries
Netherlands
Outcome results
None listed