Tailored Treatment of Permanent Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: Medtronic Cardiac Ablation System; Class I or III Antiarrhythmic Medications
Intervention description: Arm 1 (Ablation Management): Ablation procedures using investigational catheters in left atrium. Cardioversion could be used to restore sinus rhythm if needed.; Arm 2 (Medical Management): Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current cardioversions were also allowed at the discretion of the investigator.
Intervention MeSH terms: Anti-Arrhythmia Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 210.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: atrial fibrillation

Summary:

      The purpose of this trial is to evaluate the safety and efficacy of the Medtronic Cardiac
      Ablation System compared to medical therapy in the persistent and long-standing persistent
      atrial fibrillation population.
    

Eligibility criteria:

        INCLUSION CRITERIA:

          -  History of symptomatic, continuous atrial fibrillation defined as: Continuous atrial
             fibrillation lasting greater than 1 year but less than 4 years or nonself-terminating
             atrial fibrillation, lasting greater than 7 days but no more than 1 year, with at
             least one failed direct current cardioversion. A failed cardioversion was defined as
             an unsuccessful cardioversion or one in which normal sinus rhythm was established but
             not maintained beyond 7 days.

          -  Atrial fibrillation symptoms included the following: palpitations, fatigue,exertional
             dyspnea, exercise intolerance

          -  Age between 18 and 70 years

          -  Failure of at least one Class I or III rhythm control drug

          -  Willingness, ability and commitment to participate in baseline and follow-up
             evaluations for the full length of the study.

        EXCLUSION CRITERIA:

          -  Structural heart disease of clinical significance including:

               -  Previous cardiac surgery (excluding coronary artery bypass graft and mitral valve
                  repair)

               -  Symptoms of congestive heart failure including, but not limited to, New York
                  Heart Association (NYHA) Class III or IV congestive heart failure and/or
                  documented ejection fraction <40% measured by acceptable cardiac testing

               -  Left atrial diameter >55 mm

               -  Moderate to severe mitral or aortic valvular heart disease

               -  Stable/unstable angina or ongoing myocardial ischemia

               -  Myocardial infarction (MI) within 3 months of enrollment

               -  Congenital heart disease (not including atrial septal defect or patent foramen
                  ovale without a right to left shunt) where the underlying abnormality increases
                  the risk of an ablative procedure

               -  Prior atrial septal defect of patent foramen ovale closure with a device using a
                  percutaneous approach

               -  Hypertrophic cardiomyopathy (left ventricular septal wall thickness >1.5 cm)

               -  Pulmonary hypertension (mean or systolic pulmonary artery pressure >50 mm Hg on
                  Doppler echo)

          -  Any prior ablation for atrial fibrillation

          -  Enrollment in any other ongoing arrhythmia study

          -  Any ventricular tachyarrhythmia currently being treated where the arrhythmia or the
             management may interfere with this study

          -  Active infection or sepsis

          -  Any history of cerebral vascular disease including stroke or transient ischemic
             attacks

          -  Pregnancy or lactation

          -  Left atrial thrombus at the time of ablation

          -  Untreatable allergy to contrast media

          -  Any diagnosis of atrial fibrillation secondary to electrolyte imbalance, thyroid
             disease, or any other reversible or non-cardiovascular causes

          -  History of blood clotting (bleeding or thrombotic) abnormalities

          -  Known sensitivities to heparin or warfarin

          -  Severe chronic obstructive pulmonary disease (defined as forced expiratory volume 1
             (FEV1) <1)

          -  Severe co-morbidity or poor general physical/mental health that, in the opinion of the
             investigator, will not allow the subject to be a good study candidate