Safety and Effectiveness of TactiFlex* Ablation Catheter, Sensor Enabled* (TactiFlex SE) for the Treatment of Drug Refractory, Symptomatic, Paroxysmal Atrial Fibrillation (TactiFlex PAF IDE Trial)
- Conditions
- arrhytmiasymptomatic paroxysmal atrial fibrillation (PAF)10007521
- Registration Number
- NL-OMON49407
- Lead Sponsor
- St. Jude Medical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 60
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.
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 < 35% measured within 180 days of
procedure (echocardiography or CT)
9. New York Heart Association (NYHA) class III or IV
10. Previous left atrial surgical or catheter ablation procedure
11. Left atrial surgical procedure or incision with resulting scar (including
LAA closure device)
12. Previous tricuspid or mitral valve replacement or repair
13. Heart disease in which corrective surgery is anticipated within 180 days
after the procedure
14. Bleeding diathesis or suspected pro-coagulant state
15. Contraindication to long term anti-thromboembolic therapy
16. Presence of any condition that precludes appropriate vascular access
17. Renal failure requiring dialysis
18. Known sensitivity to contrast media (if needed during the procedure) that
cannot be controlled with pre-medication
19. 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
20. Women who are pregnant or breastfeeding
21. Presence of other anatomic or comorbid condition that, in the
investigator*s opinion, could limit the patient*s ability to participate in the
clinical trial or to comply with follow up requirements, or impact the
scientific soundness of the clinical trial results
22. Patient is currently participating in another clinical trial or has
participated in a clinical trial within 30 days prior to screening that may
interfere with this clinical trial
23. Patient is unlikely to survive the protocol follow up period of 12-months
after the procedure
24. Body mass index > 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary safety endpoint is the rate of device and/or procedure-related<br /><br>serious adverse events with onset within 7-days of any ablation procedure that<br /><br>uses the TactiFlex SE catheter (initial or repeat procedure performed 31-80<br /><br>days of initial procedure) that are defined below:<br /><br>• Atrio-esophageal fistula1<br /><br>• Cardiac tamponade/perforation1<br /><br>• Death<br /><br>• Heart block<br /><br>• Myocardial infarction<br /><br>• Pericarditis<br /><br>• Phrenic nerve injury resulting in diaphragmatic paralysis<br /><br>• Pulmonary edema<br /><br>• Pulmonary vein stenosis1<br /><br>• Stroke/cerebrovascular accident<br /><br>• Thromboembolism<br /><br>• Transient ischemic attack<br /><br>• Vagal nerve injury/gastroparesis<br /><br>• Vascular access complications (including major bleeding events2)</p><br>
- Secondary Outcome Measures
Name Time Method <p>not applicable</p><br>