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Sponsored by: |
IRCCS San Raffaele |
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Information provided by: | IRCCS San Raffaele |
ClinicalTrials.gov Identifier: | NCT00340314 |
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.
Condition | Intervention | Phase |
---|---|---|
Atrial Fibrillation |
Procedure: Circumferential Pulmonary Vein Ablation Drug: Antiarrhythmic Drug Therapy |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Controlled Randomized Trial of Circumferential Pulmonary Vein Ablation Versus Antiarrhythmic Drug Therapy in Treating Paroxysmal Atrial Fibrillation. The Ablation for Paroxysmal Atrial Fibrillation (APAF) Trial |
Estimated Enrollment: | 198 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | May 2006 |
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 have serious potential adverse effects, thus often offsetting any advantage offered by the maintenance of sinus rhythm (SR).2,3 Data from our and other laboratories suggest that pulmonary vein ablation techniques may be a curative alternative for AF, obviating the need for ADT and/or anticoagulation in many patients.4-8 However, only preliminary and frequently non-randomized data exists for an evidence-based evaluation of catheter ablation as compared to conventional antiarrhythmic drug therapyADT.4,8 Thus, we conducted a controlled randomized trial (the Ablation for Paroxysmal Atrial Fibrillation [APAF] trial) to determine the long-term efficacy of circumferential pulmonary vein ablation (CPVA) in patients with paroxysmal AF as compared with ADT with flecainide, sotalol or amiodarone.
Methods: One hundred ninety-eight patients (age, 56±10 years) with PAF (duration, 6±5 years, mean AF episodes 3.4/month), were randomized to CPVA or to ADT with flecainide, sotalol or amiodarone. Ablation was randomly performed with the use of a standard or an irrigated tip catheter and with CARTO or NavX non fluoroscopic 3D systems guidance. Cardiac rhythm was assessed with daily transtelephonic transmissions over a 12-month follow-up.
Crossovers to CPVA were allowed after 3 months of ADT. Results: By Kaplan-Meier analysis, 86% of patients in the CPVA group and 22% in the ADT group were free from recurrent atrial tachyarrhythmias ([AT] P<0.001); a repeat ablation was performed in 9% of patients in the CPVA group for recurrent AF (6%) or atrial tachycardia (3%). At 1 year, 93% and 35% of the CPVA and ADT groups were AT-free. Lower left ejection fraction, arterial hypertension and age independently predicted AF recurrences in the ADT group. CPVA was associated with a significant decrease in left atrial diameter (15±10%, P<0.01) and with fewer number of cardiovascular hospitalizations (p<0.01). Ablation with an irrigated tip catheter was more effective (P=0.03) with either the CARTO or NavX system (P=0.08). One transient ischemic attack and one pericardial effusion occurred in the CPVA group; side effects of ADT were reported in 23 patients.
Conclusions: Compared to ADT, CPVA can safely and effectively cure PAF in over 93% of the patients at one-year follow-up.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contraindications for antiarrhythmics therapy including flecainide, sotalol or amiodarone not listed above:
Italy | |
San Raffaele University Hospital | |
Milan, Italy, 20132 |
Principal Investigator: | Carlo Pappone, MD, PhD | San Raffaele University Hospital |
Study Chair: | Vincenzo Santinelli, MD | San Raffaele University Hospital |
Study ID Numbers: | APAF/01 |
Study First Received: | June 19, 2006 |
Last Updated: | June 26, 2006 |
ClinicalTrials.gov Identifier: | NCT00340314 History of Changes |
Health Authority: | Italy: National Monitoring Centre for Clinical Trials - Ministry of Health |
symptomatic paroxysmal atrial fibrillation |
Heart Diseases Cardiovascular Agents Anti-Arrhythmia Agents Atrial Fibrillation Arrhythmias, Cardiac |
Pathologic Processes Heart Diseases Therapeutic Uses Cardiovascular Diseases Cardiovascular Agents |
Anti-Arrhythmia Agents Atrial Fibrillation Pharmacologic Actions Arrhythmias, Cardiac |