volt ce mark study

Conditions: Atrial Arrhythmia; Atrial Fibrillation; Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation

Summary: this clinical investigation is intended to demonstrate safety and effectiveness of the volt™ pulsed field ablation (pfa) catheter sensor enabled™, the volt™ pfa generator, agilis™ nxt steerable introducer dual-reach™, and ensite™ x ep system ensite™ pulsed field ablation module (for simplicity of reference this device collection will hereafter be referred to as the volt™ pfa system) for the treatment of symptomatic, recurrent, drug-refractory paroxysmal and persistent atrial fibrillation.

the main study is a pre-market, prospective, single-arm, non-randomized, multicenter clinical study to demonstrate safety and effectiveness for the treatment of symptomatic, recurrent, drug-refractory paroxysmal atrial fibrillation (paf) and persistent atrial fibrillation (persaf). the main study design includes a feasibility sub-study in which additional imaging assessments will be collected in a small cohort of subjects to confirm acute safety of the volt pfa system in humans. the enrollment extension will include up to an additional 100 subjects enrolled with market-released or investigational devices, depending on enrollment geography.

Eligibility criteria:
inclusion criteria: 1. documented symptomatic paf or persaf. documentation requirements are as follows: paroxysmal: * physician's note indicating recurrent self-terminating af with ≥ 2 episodes of paf within the 6 months prior to enrollment and * one electrocardiographically documented paf episodes within 12 months prior to enrollment. persistent: continuous af sustained beyond 7 days and less than 1 year that is documented by * physician's note, and either * 24-hour holter within 180-days prior to enrollment, showing continuous af, or * two electrocardiograms (from any form of rhythm monitoring) showing continuous af: * that are taken at least 7 days apart but less than 12 months apart * if electrograms are more than 12 months apart, there must be one or more sinus rhythm recordings in between or within 12 months prior to consent/enrollment * the most recent electrocardiogram must be within 180 days of enrollment. note: documented evidence of the af episode must either be continuous af on a 12-lead ecg or include at least 30 seconds of af from another ecg device. 2. plans to undergo a pvi catheter ablation procedure due to symptomatic paf or persaf and is refractory, intolerant, or contraindicated to at least one class i-iv aad medication 3. at least 18 years of age 4. able and willing to comply with all trial requirements including pre-procedure, post- procedure, and follow-up testing and requirements 5. informed of the nature of the trial, agreed to its provisions, and has provided written informed consent as approved by the institutional review board/ethics committee (irb/ec) of the respective clinical trial site. exclusion criteria: 1. previously diagnosed long-standing persistent atrial fibrillation (af greater than 1 year in duration) 2. arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, electrolyte imbalance, severe untreated sleep apnea, and other major surgical procedures in the preceding 90 days 3. participant known to require ablation beyond pvi at the time of consent (main study only) 4. known presence of cardiac thrombus 5. left atrial diameter ≥ 5.5 cm (anteroposterior diameter) 6. left ventricular ejection fraction \< 35% as assessed with echocardiography within 180 days of index procedure 7. new york heart association (nyha) class iii or iv heart failure 8. body mass index \> 40 kg/m2 9. pregnant, nursing, or planning to become pregnant during the clinical investigation follow-up period 10. patients who have had a ventriculotomy or atriotomy within the preceding 28 days of procedure, 11. myocardial infarction (mi), acute coronary syndrome, percutaneous coronary intervention (pci), or valve or coronary bypass grafting surgery within preceding 90 days 12. unstable angina 13. stroke or tia (transient ischemic attack) within the last 90 days 14. heart disease in which corrective surgery is anticipated within 180 days after procedure 15. history of blood clotting or bleeding abnormalities including thrombocytosis, thrombocytopenia, bleeding diathesis, or suspected anti-coagulant sate 16. contraindication to long term anti-thromboembolic therapy 17. patient unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation 18. known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication 19. previous left atrial surgical or catheter ablation procedure (including laa closure device) 20. presence of any condition that precludes appropriate vascular access 21. severe mitral regurgitation (regurgitant volume ≥ 60 ml/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2). 22. previous tricuspid or mitral valve replacement or repair 23. patients with prosthetic valves 24. patients with a myxoma 25. patients with an interatrial baffle or patch as the transseptal puncture could persist and produce an iatrogenic atrial shunt 26. stent, constriction, or stenosis in a pulmonary vein 27. rheumatic heart disease 28. hypertrophic cardiomyopathy 29. diagnosed with amyloidosis or atrial amyloidosis 30. active systemic infection 31. renal failure requiring dialysis 32. severe 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 33. presence of an implantable therapeutic cardiac device including permanent pacemaker, biventricular pacemaker, or any type of implantable cardiac defibrillator (with or without biventricular pacing function) or planned implant of such a device for any time during the follow-up period. presence of an implantable loop recorder is acceptable as long as it is removed prior to insertion of the investigational device. 34. presence of an implanted laa closure device or plans to have an laa closure device implanted during the follow-up period 35. patient is currently participating in another clinical trial or has participated in a clinical trial within 30 days prior to screening that may interfere with this clinical trial without pre-approval from this study sponsor 36. unlikely to survive the protocol follow up period of 12 months 37. presence of other medical, anatomic, comorbid, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results. 38. individuals without legal authority 39. individuals unable to read or write

Keywords: atrial arrhythmia pulsed field ablation paroxysmal af pfa persistent atrial fibrillation