The purpose of this multicenter, comparative, randomized (1:1) study is to compare the effect of percutaneous catheter ablation versus current medical therapy on total mortality among patients with atrial fibrillation.

Kathy Avara, Research Coordinator
Email: kavara1@jhmi.edu
(410) 502-5616

Catheter Ablation versus Antiarrhythmic Drug Therapy for Atril Fibrillation

NA_00031819

Inclusions / Exclusions:

Patients who have new onset or under-treated paroxysmal, persistent, or longstanding persistent atrial fibrillation and who warrant therapy for their arrhythmia will be considered for enrollment.

Inclusions:

1. Have paroxysmal AF episodes ≥1 hour in duration; with ≥2 episodes over the preceding 6 months with electrocardiographic documentation of at least 1 episode; or 1 persistent or longstanding persistent episode of AF lasting more than 1 week.
2. Warrant active therapy beyond simple ongoing observation
3. Be eligible for catheter ablation and ≥2 sequential rhythm control and/or ≥3 rate control drugs.
4. Be ≥65 yrs of age, or <65 yrs with one or more of the following risk factors for stroke:
   • Hypertension (treated and/or defined as a BP >140/90 mmHg) [90],
   • Diabetes (treated and/or defined as a fasting glucose ≥126 mg/dl) [91],
   • Congestive heart failure (including systolic or diastolic heart failure),
   • Prior stroke or TIA, LA size >5.0 cm (or volume index ≥40 cc/m2), or EF ≤35.
   • Subjects <65 yrs of age whose only risk factor is hypertension must have a second risk factor or LV hypertrophy to qualify.
5. Have the capacity to understand and sign an informed consent form.
6. Be ≥18 years of age.
   

Exclusions:

If a subject has any of the following criteria, he or she may not be enrolled in the study:

1. Lone AF in the absence of risk factors for stroke in patients <65 years of age
2. Patients who in the opinion of the managing clinician should not yet receive any therapy for AF
3. Patients who have failed >2 membrane active anti-arrhythmic drugs at a therapeutic dose due to inefficacy or side effects
4. More than one week of amiodarone treatment in the past 3 months
5. An efficacy failure of full dose amiodarone treatment >12 weeks duration at any time
6. Reversible causes of AF including thyroid disorders, acute alcohol intoxication, recent major surgical procedures, or trauma
7. Recent cardiac events including MI, PCI, or valve or bypass surgery in the preceding 3 months
8. Hypertrophic obstructive cardiomyopathy (outflow track)
9. Class IV angina or Class IV CHF (including past or planned heart transplantation)
10. Other arrhythmias mandating anti-arrhythmic drug therapy (i.e. VT, VF)
11. Heritable arrhythmias or increased risk for torsade de pointes with class I or III drugs
12. Prior LA catheter ablation with the intention of treating AF
13. Prior surgical interventions for AF such as the MAZE procedure
14. Prior AV nodal ablation
15. Patients with other arrhythmias requiring ablative therapy
16. Contraindication to appropriate anti-coagulation therapy
17. Renal failure requiring dialysis
18. Medical conditions limiting expected survival to <1 year
19. Women of childbearing potential (unless post-menopausal or surgically sterile)
20. Participation in any other clinical mortality trial (Participation in other non-mortality trials should be reviewed with the clinical trial management center)
    

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