A Trial of Circumferential Pulmonary Vein Ablation (CPVA) Versus Antiarrhythmic Drug Therapy in for Paroxysmal Atrial Fibrillation (AF)
NCT00340314 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 198
Last updated 2010-07-28
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.
Conditions
Interventions
- PROCEDURE
-
Circumferential Pulmonary Vein Ablation
- DRUG
-
Antiarrhythmic Drug Therapy
Sponsors & Collaborators
-
IRCCS San Raffaele
lead OTHER
Principal Investigators
-
Carlo Pappone, MD, PhD · San Raffaele University Hospital, Villa Maria Cecilia Hospital, Cotignola (Ravenna), Italy
-
Vincenzo Santinelli, MD · San Raffaele University Hospital, Villa Maria Cecilia Hospital, Cotignola (Ravenna), Italy
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-01-31
- Completion
- 2006-05-31
Countries
- Italy
Study Locations
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