Review of the Safety and Effectiveness of the THERMOCOOL SMARTTOUCH® SF Catheter Evaluated for Treating Symptomatic PersistenT AF (PRECEPT)

Overview

About this study

This is a prospective, multicenter, non-randomized clinical evaluation utilizing the THERMOCOOL SMARTTOUCH® SF catheter compared to a predetermined performance goal.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Candidates for this study must meet ALL of the following criteria:

  1. Documented symptomatic persistent AF, which is defined as continuous AF sustains beyond 7 days and less than 1 year and is documented by the following:.
    1. Physician's note indicating continuous AF ≥ 7 days but no more than 1 year; AND
    2. Two electrocardiograms (from any forms of rhythm monitoring) showing continuous AF, with electrocardiogram taken at least 7 days apart OR
    3. 24-hour Holter within 90 days of the ablation procedure showing continuous AF
  2. Failed at least one antiarrhythmic drug (AAD) (class I or III) as evidenced by recurrent symptomatic AF, or intolerable to the AAD.
  3. Age 18 years or older.
  4. Signed Patient Informed Consent Form (ICF).
  5. Able and willing to comply with all pre-, post-, and follow-up testing and requirements.

Exclusion Criteria:

Candidates for this study will be EXCLUDED from the study if ANY of the following conditions apply:

  1. Continuous AF > 12 months (1-Year) (Longstanding Persistent AF)
  2. Previous surgical or catheter ablation for atrial fibrillation
  3. Any cardiac surgery within the past 2 months (60 days) (includes PCI)
  4. CABG surgery within the past 6 months (180 days)
  5. Valvular cardiac surgical/percutaneous procedure (i.e., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve)
  6. Any carotid stenting or endarterectomy
  7. Documented LA thrombus on imaging
  8. LA size > 50 mm (parasternal long axis view)
  9. LVEF < 40%
  10. Contraindication to anticoagulation (heparin or warfarin)
  11. History of blood clotting or bleeding abnormalities
  12. MI within the past 2 months (60 days)
  13. Documented thromboembolic event (including TIA) within the past 12 months (365 days)
  14. Rheumatic Heart Disease
  15. Uncontrolled heart failure or NYHA function class III or IV
  16. Severe mitral regurgitation (Regurgitant volume ≥ 60 mL/beat, Regurgitant fraction ≥ 50%, and/or Effective regurgitant orifice area ≥ 0.40cm2)
  17. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days)
  18. Unstable angina
  19. Acute illness or active systemic infection or sepsis
  20. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
  21. Diagnosed atrial myxoma.
  22. Presence of implanted ICD/CRT-D.
  23. Significant 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 chronic symptoms.
  24. Gastroesophageal Reflux Disease (GERD; active requiring significant intervention not including OTC medication)
  25. Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.
  26. Women who are pregnant (as evidenced by pregnancy test if pre-menopausal)
  27. Enrollment in an investigational study evaluating another device, biologic, or drug.
  28. Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter.
  29. Presence of any other condition that precludes appropriate vascular access.
  30. Life expectancy less than 12 months

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Douglas Packer, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20308217

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