This clinical study is a prospective, multicenter, single-arm clinical evaluation of the Multi-Electrode Radiofrequency (RF) Balloon catheter. The purpose of this study is to evaluate the overall safety and effectiveness of the Multi-Electrode RF Balloon catheter, in conjunction with the Multi-Electrode Circular Diagnostic catheter and Multi-Channel RF Generator, for the treatment of drug refractory Paroxysmal Atrial Fibrillation (PAF). Embedded within the Main Study will be a Neurological Assessment Evaluable (NAE) subset and a Cardiac Computed Tomography (CT) or Magnetic Resonance Angiogram (MRA) image (CT/MRA) subset with consecutive enrollment and a prospective design. The same subject can participate in both the NAE and cardiac CT/MRA subsets. The study will enroll subjects with drug refractory, symptomatic PAF who are candidates for catheter ablation. The first 1-3 subjects for each ablating physician will be considered roll-in subjects to verify consistent workflow for study device components and to minimize any learning curve effects. The roll-in subjects will not be included in the NAE subset, cardiac CT/MRA subset, or in the primary endpoint analyses. The roll-in phase will include a maximum of 240 subjects and the main study phase will include a maximum of 400 evaluable subjects. Subjects will be evaluated prior to the procedure, prior to discharge, and post procedure at 7 days (7-14 days), 1 month (23-37 days), 3 months (76- 104 days), 6 months (150-210 days), and 12 months (315-405 days) unless otherwise specified in the protocol.More
1.Diagnosed with Symptomatic PAF (Physician’s note indicating recurrent self terminating AF). Failed at least one (1) Class I or Class III AAD as evidenced by recurrent symptomatic AF, contraindication to the AAD, or intolerable side effects to the AAD. 3. Age 18 -75 years.
Detailed Eligibility: Study Inclusion criteria: 1. Diagnosed with Symptomatic PAF (Physician’s note indicating recurrent selfterminating AF). a) At least two (2) symptomatic AF episodes within last six (6) months from enrollment. b) At least one (1) electrocardiographically documented AF episode within twelve (12) months prior to enrollment. Electrocardiographic documentation may include, but is not limited to, electrocardiogram (ECG), Holter monitor, or telemetry strip. 2. Failed at least one (1) Class I or Class III AAD as evidenced by recurrent symptomatic AF, contraindication to the AAD, or intolerable side effects to the AAD. 3. Age 18 -75 years. 4. Able and willing to comply with all pre-procedure, post-procedure, and followup testing and visit requirements. 5. Signed Patient Informed Consent Form (ICF). Study Exclusion criteria: 1. AF secondary to electrolyte imbalance, thyroid disease, or reversible or noncardiac cause (e.g. documented obstructive sleep apnea and acute alcohol toxicity). 2. Previous surgical or catheter ablation for AF. 3. Patients known to require ablation outside the PV ostia and CTI region (e.g. atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, atrial tachycardia, ventricular tachycardia and Wolff-Parkinson- White). 4. Previously diagnosed with persistent or long-standing persistent AF and/or Continuous AF > 7 days. 5. Any percutaneous coronary intervention within the past 2 months. 6. Valve repair or replacement or presence of a prosthetic valve. 7. Any carotid stenting or endarterectomy within the past 6 months. 8. Coronary artery bypass grafting, cardiac surgery (e.g., ventriculotomy, atriotomy), or valvular cardiac surgical procedure within the past 6 months. 9. Documented left atrium (LA) thrombus within 1 day prior to the index 10. LA antero posterior diameter > 50 mm. 11. Left Ventricular Ejection Fraction (LVEF) < 40%. 12. Contraindication to anticoagulation (e.g., heparin). 13. History of blood clotting or bleeding abnormalities. 14. Myocardial infarction within the past 2 months. 15. Documented thromboembolic event (including transient ischemic attack) within the past 12 months. 16. Rheumatic Heart Disease. 17. Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV. 18. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months. 19. Unstable angina. 20. Acute illness or active systemic infection or sepsis. 21. Diagnosed atrial myxoma or presence of an interatrial baffle or patch. 22. Presence of implanted pacemaker or implantable cardioverter defibrillator (ICD). 23. 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 chronic symptoms. 24. Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in this study. 25. Women who are pregnant (as evidenced by pregnancy test if premenopausal), lactating, or who are of child bearing age and plan on becoming pregnant during the course of the clinical investigation. 26. Enrolled in an investigational study evaluating another device, biologic, or drug. 27. Has known pulmonary vein stenosis. 28. Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter. 29. Presence of an inferior vena cava filter. 30. Presence of a condition that precludes vascular access. 31. Life expectancy or other disease processes likely to limit survival to less than 12 months. 32. Presenting contra-indication for the devices (e.g., TTE, Holter, CT, etc.) used in the study, as indicated in the respective instructions for use. procedure.
Not Applicable - Describes studies without FDA-defined phases, including studies of devices or behavioral interventions.
University of Colorado Hospital
Protocol Number: 19-1679
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