Summary

Eligibility
for people ages 18-130 (full criteria)
Location
at San Diego, California and other locations
Dates
study started
estimated completion

Description

Summary

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).

Official Title

Safety and Effectiveness of TactiFlex™ Ablation Catheter, Sensor Enabled™ (TactiFlex SE) for the Treatment of Drug Refractory, Symptomatic, Atrial Fibrillation

Details

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.

Keywords

Paroxysmal Atrial Fibrillation Atrial Fibrillation TactiFlex SE TactiFlex SE - HSP HSP Sub-Study

Eligibility

You can join if…

Open to people ages 18-130

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.

You CAN'T join if...

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).

Locations

  • University of California at San Diego (UCSD) Medical Center
    San Diego California 92103 United States
  • Scripps Health
    La Jolla California 92037 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Abbott Medical Devices
ID
NCT04356040
Study Type
Interventional
Last Updated