Safety and Effectiveness Evaluation of the THERMOCOOL SMARTTOUCH SF Catheter with the TRUPULSE Generator for treatment of drug refractory symptomatic Paroxysmal Atrial Fibrillation (PAF)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Paroxysmal Atrial Fibrillation
  • Age: Between 18 Year(s) - 75 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Symptomatic paroxysmal Atrial Fibrillation (AF) with
      • At least two (2) symptomatic AF episodes within last six (6) months from enrollment,
      • At least one (1) AF episode electrocardiographically documented by electrocardiogram (ECG); Transtelephonic monitoring (TTM), Holter monitor, telemetry strip or implanted device within 12 months prior to enrollment or
      • A physician’s note indicating recurrent self-terminating AF within 7 days
    2. Failed at least one (1) Antiarrhythmic Drug (AAD) (Class I or Class III) as evidenced by recurrent symptomatic AF, intolerable side effects to the AAD, or contraindication to the AAD
    3. Age 18-75 years
    4. Willing and capable of providing consent
    5. Able and willing to comply with all pre-, post- and follow-up testing and requirements.

You may not be eligible for this study if the following are true:

    1. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (e.g., documented obstructive sleep apnea, acute alcohol toxicity, etc.)
    2. Previously diagnosed with persistent AF (> 7 days in duration)
    3. Previous Left Atrium (LA) ablation or surgery
    4. Patients known to require ablation outside the Pulmonary Vein (PV) region (e.g., atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, ventricular tachycardia and Wolff-Parkinson-White), except Cavotricuspid Isthmus (CTI) lines for the ablation of typical right atrial flutter.
    5. Documented severe dilatation of the LA (LAD >50mm) antero-posterior diameter on imaging within 6 months prior to enrollment.
    6. Documented LA thrombus by imaging within 48 hours of the procedure.
    7. Documented severely compromised Left Ventricular Ejection Fraction (LVEF) (LVEF <40%) by imaging within 6 months prior to enrollment
    8. Uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV
    9. History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin) except subjects with prior left atrial appendage closure
    10. Documented thromboembolic event (including Transient Ischemic Attack (TIA)) within the past 12 months
    11. Patients with unstable angina, percutaneous coronary intervention or acute myocardial infarction within 2 months
    12. Coronary Artery Bypass Grafting (CABG) surgery within the past 6 months (180 days)
    13. Valvular cardiac surgical/percutaneous procedure (i.e., ventriculotomy, atriotomy, valve repair or replacement and presence of a prosthetic valve).
    14. Unstable angina within 6 months
    15. Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months.
    16. 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 severe chronic symptoms.
    17. Significant congenital anomaly (e.g., ASDs) including repaired defects
    18. Prior diagnosis of pulmonary vein stenosis
    19. Pre-existing hemi diaphragmatic paralysis
    20. Acute illness, active systemic infection, or sepsis
    21. Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation.
    22. Presence of implanted pacemaker, Implantable Cardioverter-Defibrillator (ICD), recently implanted (within 6 months) LAAO device or other implanted metal cardiac device within the cardiac space that may interfere with the energy field created during the ablation procedure.
    23. Presence of a condition that precludes vascular access
    24. Current enrollment in an investigational study evaluating another device or drug.
    25. Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of child-bearing age and plan on becoming pregnant during the course of the clinical investigation.
    26. Life expectancy less than 12 months



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