VOLT AF IDE

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 30

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 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 180 days prior to enrollment, showing continuous AF, OR
• Two electrocardiograms (from any form of rhythm monitoring) showing
continuous AF:
o That are taken at least 7 days apart but less than 12 months apart
o 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
o 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
(Continuous 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. Patient known to require ablation beyond PVI at the time of consent.
4. Known presence of cardiac thrombus
5. Left atrial diameter >= 5.5 cm (anteroposterior diameter) within 180 days of
index procedure.
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 30
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 state
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 left atrial 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