Atrial Fibrillation Irregular Heartbeat
Conditions
Interventions
The Volt PFA Catheter, Sensor Enabled™ (Volt™ PFA Catheter, SE) is a sterile, single use, balloon filled basket catheter that is used for intracardiac mapping, pacing, and therapy energy delivery duri
The catheter has an inflation lumen for inflation and deflation of the balloon. There is also a center lumen in the catheter with a hemostasis hub that allows for guidewire introduction through the de
There is an integrated connecting cable that extends from the proximal end of the handle to connect to the compatible PFA Generator (also known as the Current™ PFA Generator). Refer to Figure 2 for il
Sponsors
St. Jude Medical
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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: 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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Safety will be summarized as the rate of subjects experiencing a device and/or procedure-related serious adverse event with onset within 7-days of any ablation procedure (index or repeat procedure) that uses the Volt PFA System that are defined below: • Atrio-esophageal fistula • Cardiac tamponade/perforation • Death • Heart block • Myocardial infarction • Pericarditis • Phrenic nerve injury resulting in permanent diaphragmatic paralysis • Pulmonary Edema • Pulmonary vein stenosis • Stroke • Thromboembolism • Transient ischemic attack • Vagal nerve injury/gastroparesis • Major vascular access complications4 / major bleeding eventsAF, AFL, and/or AT recurrences without coexisting conditions (e.g., thromboembolism, worsening heart failure, etc.) will be counted as effectiveness failures but will not count against the primary safety endpoint.Effectiveness: Acute procedural effectiveness is defined as confirmation of entrance block in all targeted pulmonary veins, with a secondary measure of confirmation to include any one of the following (the same method must be used for all pulmonary veins): • 20-minute wait following initial PVI, followed by a second confirmation of entrance block in each pulmonary vein; or • Exit block using a multipolar catheter; or • Isoproterenol or adenosine challengeEntrance block is the absence of wavefront propagation from the left atrium (LA) to the PV and will be confirmed via the disappearance or dissociation of PV potentials with a multipolar catheter. The Volt PFA Catheter may be used for verification of entrance block.Long-term effectiveness will be the proportion of subjects with freedom from documented AF/AFL/AT recurrence through 12-months follow-up (after a 90 day-blanking period following the index ablation procedure). AFL recurrence must be non-CTI dependent (typical) atrial flutter. AF/AFL/AT recurrence is defined as:Documented AF/AFL/AT episodes of > 30 seconds duration following the 90-day blanking period. Doc | — |
Secondary
| Measure | Time frame |
|---|---|
| Not applicable. | — |
Countries
Austria, Belgium, Denmark, France, Ireland, Italy, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland
Contacts
Public ContactM Van Dongen
St. Jude Medical
Outcome results
None listed