arrhytmia symptomatic paroxysmal atrial fibrillation (PAF)
Conditions
Interventions
Catheter ablation
Sponsors
St. Jude Medical
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Plans to undergo a catheter ablation procedure due to symptomatic PAF that is refractory or intolerant to at least one Class I or III antiarrhythmic drug. 2. Physician*s note indicating recurrent self-terminating AF 3. One electrocardiographically documented AF episode within 6-months prior to the initial ablation procedure. 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. 4. At least 18 years of age 5. Able and willing to comply with all trial requirements 6. 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. Persistent or long-standing persistent atrial fibrillation 2. Active systemic infection 3. Known presence of cardiac thrombus 4. Hypertrophic cardiomyopathy 5. Arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, and other major surgical procedures in the 90-day period preceding procedure 6. Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery within 90 days of procedure 7. Left atrial diameter > 5.0 cm measured within 180 days of procedure (echocardiography or CT) 8. Left ventricular ejection fraction 40 kg/m2 25. Presence of other medical, 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. 26. Individuals without legal authority 27. Individuals unable to read or write 28. Patients who have had a ventriculotomy or atriotomy within the preceding 4 weeks of procedure, 29. Patients with prosthetic valves, 30. Patients with a myxoma, 31. Patients with an interatrial baffle or patch as the transseptal puncture could persist and produce an iatrogenic atrial shunt 32. Patient unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary safety endpoint is the rate of device and/or procedure-related serious adverse events with onset within 7-days of any ablation procedure that uses the TactiFlex SE catheter (initial or repeat procedure performed 31-80 days of initial procedure) that are defined below: • Atrio-esophageal fistula1 • Cardiac tamponade/perforation1 • Death • Heart block • Myocardial infarction • Pericarditis • Phrenic nerve injury resulting in diaphragmatic paralysis • Pulmonary edema • Pulmonary vein stenosis1 • Stroke/cerebrovascular accident • Thromboembolism • Transient ischemic attack • Vagal nerve injury/gastroparesis • Vascular access complications (including major bleeding events2) | — |
Countries
Netherlands
Outcome results
None listed