CACAF2 Study: Catheter Ablation for Cure of Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: RF ablation; Antiarrhythmic drugs
Intervention description: Catheter ablation with NAVISTAR® THERMOCOOL® Catheter in conjunction with CARTO™ EP Navigation System; Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
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: 129.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The objective of this prospective multicenter randomized study is to establish the
      effectiveness of treatment of persistent atrial fibrillation by encircling the pulmonary
      veins with radiofrequency (RF) ablation and creating additional lines of block with the aid
      of the NAVISTAR® THERMOCOOL® catheter in conjunction with the CARTO™ EP Navigation System.
      Effectiveness will be determined by comparing the chronic success of ablation therapy versus
      antiarrhythmic drug therapy, defined as the absence of persistent tachyarrhythmias during the
      first 24 months after a run-in phase of 2 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18-70 years

          -  Written informed consent

          -  One documented relapse of atrial fibrillation (AF) during antiarrhythmic drug therapy
             after an electrical cardioversion

        Exclusion Criteria:

          -  Permanent atrial fibrillation

          -  Patients who had tried >1 antiarrhythmic drug (Class I or Class III).

          -  AF was the sole rhythm for >6 months before the enrollment.

          -  Previous ablation for AF.

          -  AF is deemed secondary to a transient or correctable abnormality including electrolyte
             imbalance, trauma, recent surgery, infection, toxic ingestion, and endocrinopathy.

          -  Patients who have fibrillation episodes triggered by another uniform arrhythmia (eg,
             atrial flutter or atrial tachycardia).

          -  Patients with intra-atrial thrombus, tumor, or another abnormality that precludes
             catheter introduction.

          -  Patients with Wolf-Parkinson-White syndrome.

          -  Patients awaiting cardiac transplantation.

          -  Congestive heart failure (CHF) New York Heart Association (NYHA) Class II-III-IV or
             ejection fraction (EF) <40%.

          -  Patients with unstable angina or acute myocardial infarction within 3 months.

          -  Patients with cardiac revascularization or other cardiac surgery within 6 months.

          -  Patients with heart disease in which corrective surgery is anticipated.

          -  Patients in whom appropriate vascular access is precluded.

          -  Pregnant women.

          -  A separate requirement for antiarrhythmic drug treatment, which will require an
             antiarrhythmic drug not previously tried for AF suppression.

          -  Prior atrial surgery.

          -  Contraindication to treatment with warfarin or other bleeding diathesis.

          -  Renal failure requiring dialysis.

          -  Hepatic failure.

          -  Participant in investigational clinical or device trial.

          -  Unwilling or unable to give informed consent.

          -  Inaccessible for follow-up.

          -  Psychological problem that might limit compliance.

          -  Active abuse of alcohol or other drugs which may be causative of AF.

          -  An implanted device (pacemaker or cardioverter-defibrillator).

          -  Left atrial diameter (anteroposterior) >50 mm.