TactiFlex AF IDE Trial
TactiFlex AF IDE Trial
Prospective, non-randomized multi-center clinical investigation. Design includes a main study
 and a separate substudy. Subjects in the main study are to be treated using the full range of
 ablation power settings in the IFU. Subjects in the substudy are to be treated in the upper
 end of the recommended ablation power settings (40-50 Watts).
This clinical investigation is intended to demonstrate the safety and effectiveness of the
 TactiFlexTM Ablation Catheter, Sensor EnabledTM (TactiFlex SE) for treating symptomatic
 drug-refractory paroxysmal atrial fibrillation. This clinical investigation will be conducted
 under an investigational device exemption (IDE) and is intended to support market approval of
 the TactiFlex SE catheter worldwide. Three hundred fifty-five (355) subjects will be enrolled
 at up to 50 investigational sites worldwide. This clinical investigation is sponsored by
 Abbott.

 The TactiFlex IDE Clinical Study will enroll a total of 355 subjects.
Inclusion Criteria:

 A patient will be eligible for clinical trial participation if he/she meets the following
 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.

 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:

 A patient will be excluded from enrollment in the clinical trial if he/she meets any of the
 following 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 < 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.

 33. Stroke or TIA (transient ischemic attack) within the last 90 days

 34. Stent, constriction, or stenosis in a pulmonary vein.

 35. Rheumatic heart disease

 36. Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥
 50%, and/or effective regurgitant orifice area ≥ 0.40cm2).