BaLloon-based PFA Ablation poST Approval Outcomes for PAF and PersAF

BaLloon-based PFA Ablation poST Approval Outcomes for PAF and PersAF

This study is designed to obtain real-world clinical evidence on the safety and effectiveness of the Volt PFA System in various use cases, with a sub study designed to address additional clinical evidence needs in electrophysiology.

Inclusion Criteria:

1. Documented symptomatic PAF or PersAF. Documentation requirements are as follows:

   Paroxysmal:

   • Physician's note indicating recurrent self-terminating AF AND
   • One electrocardiographically documented PAF episode 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 360 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 de novo ablation procedure with the Volt PFA Catheter 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. 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
2. Known presence of cardiac thrombus
3. Known Left ventricular ejection fraction < 35% as assessed with echocardiography within 360 days of index procedure
4. New York Heart Association (NYHA) class III or IV heart failure
5. Pregnant, nursing, or planning to become pregnant during the clinical investigation follow-up period
6. Patients who have had a ventriculotomy or atriotomy within the preceding 30 days of procedure
7. Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery within preceding 90 days
8. Unstable angina
9. Stroke or TIA (transient ischemic attack) within the last 90 days
10. Heart disease in which corrective surgery is anticipated within 180 days after procedure
11. History of blood clotting or bleeding abnormalities including thrombocytosis, thrombocytopenia, bleeding diathesis, or suspected anti-coagulant state
12. Contraindication to long term anti-thromboembolic therapy
13. Patient unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation
14. Previous left atrial surgical or left atrial catheter ablation procedure (including LAA closure device)
15. Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2).
16. Previous tricuspid or mitral valve replacement or repair
17. Patients with prosthetic valves
18. Patients with a myxoma
19. Patients with an interatrial baffle or patch as the transseptal puncture could persist and produce an iatrogenic atrial shunt
20. Stent, constriction, or stenosis in a pulmonary vein
21. Rheumatic heart disease
22. Hypertrophic cardiomyopathy
23. Diagnosed with amyloidosis or atrial amyloidosis
24. Active systemic infection
25. Renal failure requiring dialysis
26. 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
27. Presence of an implanted LAA closure device
28. Patient is currently participating in another clinical study that may confound the results of this of this post market evaluation; for example, enrolled in another study with an active treatment arm
29. Unlikely to survive the protocol follow up period of 12 months
30. 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.
31. Individuals without legal authority
32. Individuals unable to read or write