Atrial Fibrillation Progression Trial
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: Catheter Ablation; Drug Treatment
Intervention description: Treat subjects with Paroxysmal Atrial Fibrillation (PAF); Drug therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with current atrial fibrillation management guidelines.
Intervention MeSH terms: Anti-Arrhythmia Agents
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 255.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes

Summary:

      The objective of this study is to determine whether early radiofrequency (RF) ablation
      treatment, using the CARTO® 3 or CARTO® XP System, and THERMOCOOL® Catheter Family (including
      THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™) in subjects with paroxysmal atrial fibrillation
      (PAF), delays progression of atrial fibrillation (AF) compared with drug therapy (either rate
      or rhythm control) using current AF management guidelines.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with recurrent paroxysmal atrial fibrillation (AF) for at least 2 years, with
             ≥ 2 episodes over the last 6 months; (per Amendment v3, 09APR2013, previous "6
             episodes" )

          2. HATCH Score of at least ≥1 and ≤4.

          3. Eligible for catheter ablation and for anti-arrhythmic or rate control medications,
             after having failed at least 1 but no more than 2 prescribed drugs (either
             anti-arrhythmic or rate control drug).

          4. Age 60 years or older.

          5. Left atrium (LA) diameter ≤ 55mm by TTE.

          6. Left ventricle (LV) ejection fraction ≥50% when in sinus rhythm or LV ejection
             fraction ≥35% when in atrial fibrillation.

             NOTE: For patients entering the study in AF with an ejection fraction ≥35% and <50%;
             the ejection fraction should be re-checked when in sinus rhythm. In case the ejection
             fraction is >50% the subject can continue in the study.

          7. Patient signed the Informed Consent Form and is able and willing to comply with
             protocol requirements, including all baseline and follow-up testing.

        Exclusion Criteria:

          1. Patients awaiting cardiac transplantation or other cardiac surgery.

          2. Acute illness (ongoing) or active systemic infection or sepsis which in the opinion of
             the investigator, may adversely affect the safety and/or effectiveness of the
             participant of the study.

          3. Reversible causes of atrial fibrillation, e.g. but not limited to thyroid disorders,
             acute alcohol intoxication, recent major surgical procedures or trauma, etc.

          4. Recent cardiac events including myocardial infarction (MI), percutaneous coronary
             intervention (PCI), or valve or bypass surgery in the preceding 3 months.

          5. Heart failure decompensation.

          6. Previously diagnosed with persistent/permanent atrial fibrillation/ atrial flutter.

          7. Previously required cardioversion >48 hours after onset of atrial fibrillation/ atrial
             flutter.

          8. Subject having previous transischemic attack (TIA) or stroke (cerebrovascular
             accident) one year prior to patient enrolment and/or no sufficient recovery.

          9. Pulmonary embolism or recent atrial embolism/thrombosis.

         10. Hypertrophic obstructive cardiomyopathy.

         11. Class IV angina or Class IV congestive heart failure (CHF) (including past or planned
             heart transplantation).

         12. Mandated anti-arrhythmic drug therapy for disease conditions other than atrial
             fibrillation.

         13. Heritable arrhythmias or increased risk for torsade de pointes with class I or III
             Drugs.

         14. Prior left atrial catheter ablation with the intention of treating atrial
             fibrillation; prior surgical interventions for AF such as the MAZE procedure.

         15. Prior AV nodal ablation.

         16. Patients presenting contra-indications for the study catheter(s), as indicated in the
             respective Instructions For Use.

         17. Contraindication to warfarin, other anticoagulation therapy, or all anti-platelet
             medications.

         18. Medical conditions limiting expected survival to <3 years.

         19. Concurrent participation in any other clinical study.

         20. Prior history of non-adherence to prescribed drug regimens.

         21. Women of child bearing potential whom are pregnant, lactating, or planning to become
             pregnant during the course of the trial

        NOTE: Prior ablation of the cavo-tricuspid isthmus is not a reason to exclude, if the
        patient develops subsequent recurrent atrial fibrillation.

        NOTE: For patients randomized to the PVI group (Test Group), a Transesophageal
        Echocardiography (TEE) should be performed (as per standard of care), within 48 hours
        pre-procedure, to exclude atrial thrombus or other structural contraindications for an
        ablation procedure.