Atrium Fibrillation heart rhythm disturbance
Conditions
Interventions
Pulmonal Vein isolation (PVI) through Pulsed Field ablation (PFA)
Sponsors
Abbott 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 episodes within 12 months. Documented evidence of the PAF episode must either be continuous AF on a 12-lead ECG or include at least 30 seconds of AF from another ECG device. 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 the procedure, 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 with the most recent electrocardiogram within 180 days of enrollment. 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 that is refractory or intolerant to at least one Class I or III antiarrhythmic drug 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: A patient will be excluded from enrollment in the clinical trial if he/she meets any of the following 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 prior to initiating the index procedure 4. Known presence of cardiac thrombus 5. Left atrial diameter >= 5.5 cm (anteroposterior diameter) 6. Left ventricular ejection fraction 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute Safety: Acute 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 fistula1 • Cardiac tamponade/perforation2 • Death • Heart block • Myocardial infarction • Pericarditis3 • Phrenic nerve injury resulting in permanent diaphragmatic paralysis • Pulmonary edema • Pulmonary vein stenosis1 • Stroke/cerebrovascular accident • Thromboembolism • Transient ischemic attack • Vagal nerve injury/gastroparesis • Vascular access complications (including major bleeding events4) • Device and/or procedure related cardiovascular and/or pulmonary adverse event that prolongs hospitalization for more than 48 hours (excluding hospitalization solely for arrhythmia recurrence or non-urgent cardioversion) Acute Effectiveness: Acute procedural effectiveness will be summarized as the rate of pulmonary veins treated with the Volt PFA system that are isolated at the end of the index ablation procedure. Acute procedural failure for each pulmonary vein is defined as any of the following: 1. Inability to isolate a pulmonary vein at the end of the index ablation procedure. Isolation will be assessed via confirmation of electrical isolation in each ablated pulmonary vein after a minimum waiting period of 20 minutes via entrance block at a minimum. Touch-up ablation to achieve isolation will be allowed for any pulmonary vein reconnection detected during the index procedure with the investigational catheter (to the maximum delivery allowed per vein) and will not be considered a failure. 2. Any use of a non-study ablation device for pulmonary vein isolation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. 12-month effectiveness: Freedom from documented (symptomatic or asymptomatic) AF/AFL/AT episodes of >=30 seconds duration that are documented by protocol-specified 12-lead ECG, transtelephonic monitoring (TTM) or Holter monitor after the initial catheter ablation procedure through 12 months of follow-up (after a 90-day blanking period following the initial ablation procedure). The situations in which subjects will be considered 12-month effectiveness endpoint failures are those listed below: • Acute procedural failure occurs, defined as the inability to isolate all targeted pulmonary veins using only the Volt PFA Catheter for ablation. Isolation will be assessed via confirmation of electrical isolation (via entrance block at a minimum) in each ablated pulmonary vein after a minimum waiting period of 20 minutes. • Any use of a non-study ablation device for pulmonary vein isolation or to deliver ablation lesions in the left atrium. • If documented AF/AFL/AT recurrence (>30 second episode), excluding cavotricuspid-dependent atrial flutter that has been confirmed in an electrophysiology study (e.g. via entrainment maneuvers), occurs at any time after the blanking period (>90 days after the initial procedure) as assessed by protocol-specified 12-lead ECG, TTM, and Holter monitoring (NOTE: If the subject has a continuous atrial arrhythmia throughout a 12-lead ECG recording after the blanking period indicating AF/AFL/AT recurrence, this will be considered sufficient documentation of recurrence unless there is evidence that the recorded arrhythmia is short-lived and less than 30 seconds as determined by the investigator.). • If subject requires a repeat procedure for the treatment of AF, non-CTI-dependent AFL, or AT using a non-study ablation device. • Any use of a new class I or III AAD for AF after the blanking period. • Any use of a class I or III AAD for AF at a dose higher than the historical maximum dose for the subject. • If the subje | — |
Countries
Netherlands
Outcome results
None listed