atrium fibrillation heart rhythm disturbance
Conditions
Interventions
Pulsed Field Ablation met het TactiFlex PFA system
Sponsors
St. Jude Medical
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Documented symptomatic paroxysmal AF (PAF). Documentation requirements are as follows: a. Physician*s note indicating recurrent self-terminating AF with >= 2 episodes of PAF within the 6 months prior to enrollment AND b. One electrocardiographically documented PAF episode within 12 months prior to 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 continuous AF from another ECG device. 2. Plans to undergo a catheter ablation procedure due to symptomatic PAF 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. Previously diagnosed persistent or 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. Known presence of cardiac thrombus 4. Left atrial diameter (LAD) > 5.0 cm (anteroposterior diameter) within 180 days prior to the index procedure 5. Left ventricular ejection fraction (LVEF) 40 kg/m2 8. Pregnant or nursing 9. Patients who have had a ventriculotomy or atriotomy within the preceding 28 days of procedure 10. Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery within preceding 90 days 11. Stroke or TIA (transient ischemic attack) within the last 90 days 12. Heart disease in which corrective surgery is anticipated within 180 days after procedure 13. History of blood clotting or bleeding abnormalities including thrombocytosis, thrombocytopenia, bleeding diathesis, or suspected anti-coagulant state 14. Contraindication to long-term anti-thromboembolic therapy 15. Patient unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation 16. Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication 17. Previous left atrial surgical or left atrial catheter ablation procedure (including left atrial appendage (LAA) closure device) 18. Plans to have an LAA closure device implanted during the follow-up period 19. Presence of any condition that precludes appropriate vascular access 20. Severe mitral regurgitation (regurgitant volume >= 60 mL/beat, regurgitant fraction >= 50%, and/or effective regurgitant orifice area >= 0.40cm2) 21. Previous tricuspid or mitral valve replacement or repair 22. Patients with prosthetic valves 23. Patients with a myxoma 24. Patients with an interatrial baffle or patch as the transseptal puncture could persist and produce an iatrogenic atrial shunt 25. Stent, constriction, or stenosis in a pulmonary vein 26. Rheumatic heart disease 27. Hypertrophic cardiomyopathy 28. Active systemic infection 29. Renal failure requiring dialysis 30. 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 31. 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. 32. Patient is currently participating in another clinical trial or has participated in a clinical trial within 30 days prior to screening t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary safety endpoint is the proportion of subjects experiencing a device and/or procedure-related serious adverse event (SAE) with onset within 7 days of any ablation procedure (index or repeat procedure performed 0-90 days post initial procedure) that uses the TactiFlex PFA System defined below: • Esophageal perforating complications1 • Cardiac tamponade/perforation2 • Death • Heart block • Myocardial infarction • Pericarditis3 • Phrenic nerve injury resulting in diaphragmatic paralysis • Pulmonary edema • Pulmonary vein stenosis1 • Stroke/cerebrovascular accident • Thromboembolism • Transient ischemic attack • Vagal nerve injury/gastroparesis • Major vascular access complications4 / major bleeding event5 • 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) The primary effectiveness endpoint for this clinical trial is freedom from documented (symptomatic or asymptomatic) AF/AFL/AT episodes of >30 seconds duration that are documented by protocol-specified 12-lead ECG, TTM or Holter monitor (HM) devices after the index ablation procedure through 12 months of follow-up (after a 90-day blanking period following the index ablation procedure). | — |
Secondary
| Measure | Time frame |
|---|---|
| The Symptomatic Secondary Effectiveness Endpoint has the same definition as the Primary Effectiveness endpoint, except that a documented recurrence without documentation of symptoms after the 90-day blanking period will not count as a therapy failure in this analysis. The AAD-Free Secondary Effectiveness Endpoint has the same definition as the Primary Effectiveness endpoint, except that any use of Class I or III AADs after the 90-day blanking period will count as a therapy failure in this analysis. Descriptive endpoints are reported using only summary statistics and no hypothesis testing will be performed. • Acute procedural effectiveness, defined as confirmation of entrance block in all pulmonary veins after a minimum waiting period of 20-minutes. • Proportion of subjects with successful first-pass isolation of all targeted veins, and proportion of all targeted pulmonary veins with successful first-pass pulmonary vein (PV) isolation. First-pass isolation is defined as confirmation of entrance block in each pulmonary vein after completion of the initial lesion set and 20-minute wait period, with no reconnection occurring during the 20-minute wait period. • 12-month single procedure effectiveness, defined the same as the Primary Effectiveness Endpoint, except that any repeat ablation procedure (excluding CTI-dependent AFL) required by the subject at any time will be deemed a failure. • Proportion of subjects requiring one or more repeat AF, non-CTI dependent AFL, or AT ablations through 12-months following the initial AF ablation procedure. Of those subjects with repeat ablations including access to the left atrium, the proportion of treated pulmonary veins ablated with reconnections, the locations and energy modality used in the area of pulmonary vein reconnections (of treated veins) upon electro-anatomical remapping. • Changes in EQ-5D-5L and AFEQT (AF Effect on Quality-Of-Life Questionnaire) scores from baseline to follow up at 3, 6, an | — |
Countries
Austria, Lithuania, Netherlands, United States
Contacts
Public ContactK.C. Peeters
St. Jude Medical
Outcome results
None listed