A Trial of Circumferential Pulmonary Vein Ablation (CPVA) Versus Antiarrhythmic Drug Therapy in for Paroxysmal Atrial Fibrillation (AF)

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Background: Circumferential pulmonary vein ablation (CPVA) has been safely and effectively performed for treating paroxysmal atrial fibrillation (PAF); however, its safety and efficacy, as compared with those of antiarrhythmic drug therapy (ADT), have never been formally assessed in a randomized controlled trial.

The Purpose of this study was to evaluate CPVA versus ADT in patients with PAF in a randomized controlled trial.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IRCCS San Raffaele
• Treatments: Anti-Arrhythmia Agents

Criteria

Inclusion Criteria:

1. Age 18-70 years

2. History of symptomatic paroxysmal AF lasting more than 6 months. Paroxysms of AF are intended as recurrent self-terminating episodes lasting less than 7 days and occurring more than 2 times every month.

Exclusion Criteria:

1. Pregnancy

2. NYHA functional class III or IV

3. Left atrial size > 65 mm

4. Left ventricular (LV) ejection fraction < 35%

5. Contraindication to anticoagulation with warfarin

6. History of myocardial infarction within six months of the procedure

7. Prior catheter or surgical ablation attempt for AF

8. Inability or unwillingness to provide written informed consent

9. Life expectancy less than 1 year

10. Significant comorbid conditions such as: cancer (not cured), end stage renal disease (creatinine clearance < 20 mL/h), severe chronic obstructive lung disease, cirrhosis, etc)

11. Anticipated cardiac surgery for congenital, valvular, aortic or coronary heart disease.

12. Presence of left atrial thrombus.

13. Prior antiarrhythmic drug therapy with amiodarone, sotalol and flecainide at optimal doses (target 200 mg, 240 mg, 200 mg daily respectively

14. AF burden < 2 episodes/month

15. WPW

16. Expected survival < 1 year

17. Contraindications for antiarrhythmics therapy including flecainide, sotalol or amiodarone not listed above:

• LV hypertrophy (LV mass index > 125g/m2)

• thyroid dysfunction (hyperthyroidism or uncontrolled hypothyroidism or thyroid cancer)

• liver dysfunction (ALT or AST >2x the reference values)

• Interstitial lung disease with DLCO<70% of predicted or severe asthma.

• QT interval exceeding 400 msec

• Symptomatic sinus node or atrioventricular node dysfunction unless a pacemaker had been implanted

• Evidence of stress-induced myocardial ischemia