Status:
COMPLETED
A Trial of Circumferential Pulmonary Vein Ablation (CPVA) Versus Antiarrhythmic Drug Therapy in for Paroxysmal Atrial Fibrillation (AF)
Lead Sponsor:
IRCCS San Raffaele
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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 wi...
Detailed Description
Antiarrhythmic drug therapy (ADT) is currently considered as first-line therapy in patients with paroxysmal atrial fibrillation (AF).1 However antiarrhythmic drugs are frequently ineffective and can h...
Eligibility Criteria
Inclusion
- Age 18-70 years
- 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
- Pregnancy
- NYHA functional class III or IV
- Left atrial size \> 65 mm
- Left ventricular (LV) ejection fraction \< 35%
- Contraindication to anticoagulation with warfarin
- History of myocardial infarction within six months of the procedure
- Prior catheter or surgical ablation attempt for AF
- Inability or unwillingness to provide written informed consent
- Life expectancy less than 1 year
- Significant comorbid conditions such as: cancer (not cured), end stage renal disease (creatinine clearance \< 20 mL/h), severe chronic obstructive lung disease, cirrhosis, etc)
- Anticipated cardiac surgery for congenital, valvular, aortic or coronary heart disease.
- Presence of left atrial thrombus.
- Prior antiarrhythmic drug therapy with amiodarone, sotalol and flecainide at optimal doses (target 200 mg, 240 mg, 200 mg daily respectively
- AF burden \< 2 episodes/month
- WPW
- Expected survival \< 1 year
- 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
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
End Date :
May 1 2006
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT00340314
Start Date
January 1 2005
End Date
May 1 2006
Last Update
July 28 2010
Active Locations (1)
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1
San Raffaele University Hospital
Milan, Italy, 20132