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Safety and Effectiveness Evaluation of THERMOCOOL SMARTTOUCHTM SF Catheter with the TRUPULSETM generator for treatment of drug refractory symptomatic paroxysmal atrial fibrillation.

Study Description

This is a prospective, single arm, multi-center, clinical evaluation of the Biosense Webster Ablation System to demonstrate safety and effectiveness of the system for the treatment of Paroxysmal Atrial Fibrillation (PAF) comparing to corresponding performance goals. The study will enroll 135 subjects with drug refractory PAF who are candidates for atrial fibrillation ablation. All subjects will be followed for 12 months and scheduled for evaluation at 7 days, 1-, 3-, 6- and 12-month following index ablation procedure. An early success interim analysis will be performed when 30% of treated subjects complete 12 months of follow-up and all subjects have at least 6 months of follow-up. The study will declare early success if both primary safety and primary effectiveness endpoints are met at the early success interim analysis.

    Primary Objective

    The primary objective of this clinical investigation is to demonstrate safety and effectiveness of the BWI Ablation System when used for isolation of the atrial PVs in treatment of subjects with PAF. Specifically:

    1. To demonstrate the safety based on early-onset (within 7 days of ablation procedure) primary adverse events.
    2. To demonstrate 12-month effectiveness off AAD based on freedom from documented symptomatic and asymptomatic atrial arrhythmia (atrial fibrillation (AF), atrial tachycardia (AT) or atrial flutter (AFL) episodes during the effectiveness evaluation period (Day 91-365).

      Secondary Objective

      The secondary objective of this clinical investigation is to evaluate Quality of Life (QOL) up to 12 months.

      Inclusion Criteria

      1. Diagnosis of symptomatic parysoxmal atrial filtration with 1 electrocardiographically documented AF episode within 12 months prior to enrolment, e.g. ECG, Holter etc
      2. At least one failed Class I or Class III AAD evidenced by recurrent symptomatic AF or has intolerable side effects or is contracted to the Class I or Class III AAD.
      3. 18-80 years of age
      4. Able and willing to comply with all pre-procedure, post-procedure and follow-up testing and visit requirements.
      5. Willing and capable of providing consent.

      Exclusion Criteria

      • 1. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (e.g., untreated documented obstructive sleep apnoea and acute alcohol toxicity).
      • 2. Previous LA ablation or surgery
      • 3. Patients known to require ablation outside the PV region (atrioventricular re-entrant tachycardia, atrioventricular nodal re-entry tachycardia, atrial tachycardia, atrial flutter of unknown origin, ventricular tachycardia and Wolff-Parkinson-White).
      • 4. Previously diagnosed with persistent AF (> 7 days in duration)
      • 5. Severe dilatation of the LA (documented LAD >50mm antero-posterior diameter on imaging within 6 months prior to enrolment
      • 6. Documented left atrium (LA) thrombus within 48 hours prior to the index procedure by TEE, or by ICE prior to transeptal puncture during procedure.
      • 7. Documented severely compromised LVEF (LVEF <40%) by imaging within 6 months prior to enrolment
      • 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, warfarin, or dabigatran)
      • 10. History of a documented thromboembolic event (including TIA) within the past 12 months, or history of a documented left atrial appendage (LAA) thrombus
      • 11. History of a documented symptomatic lacunar infarction within the past 12 months
      • 12. Previous PCI/MI within the past 2 months
      • 13. Coronary Artery Bypass Grafting (CABG) surgery within past 6 months
      • 14. Valvular surgery, cardiac surgery (e.g., ventriculostomy, atriotomy) or valvular cardiac (surgical or percutaneous) procedure.
      • 15. Unstable angina pectoris within the past 6 months
      • 16. Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months.
      • 17. 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
      • 18. Known significant PV anomaly that in the opinion of the investigator would preclude enrolment in this study
      • 19. Has known pulmonary vein stenosis
      • 20. Pre-existing hemi diaphragmatic paralysis
      • 21. Acute illness, active systemic infection, or sepsis
      • 22. Presence of intracardiac thrombus, myxoma, tumour, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation.
      • 23. Severe mitral regurgitation (Regurgitant volume 60 mL/beat, Regurgitant fraction 50%, and/or Effective regurgitant orifice area 0.40cm2)
      • 24. 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.
      • 25. Presence of a condition that precludes vascular access (such as IVC filter)
      • 26. Significant congenital anomaly or a medical problem that in the opinion of the investigator would preclude enrolment in this study
      • 27. Categorized as vulnerable population and requires special treatment with respect to safeguards of well-being
      • 28. Current enrolment in an investigational study evaluating another device or drug.
      • 29. Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of childbearing age and plan on becoming pregnant during the clinical investigation.
      • 30. Life expectancy less than 12 months
      • 31. History of massive haemorrhage within the past 6 months. 32. Presenting contra-indications for the devices