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Research

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RAAFT

Official Title

First Line Radiofrequency Ablation versus Antiarrhythmic Drugs for Atrial Fibrillation Treatment. The RAAFT Study: A Multi-Center Randomized Trial

Status

Completed

Overview

To determine whether catheter-based pulmonary vein isolation is superior to antiarrhythmic drugs as first line therapy in patients with symptomatic paroxysmal recurrent atrial fibrillation not previously treated with therapeutic doses of antiarrhythmic drugs.

Study Design

Randomized, open label, active control, parallel group design, safety/efficacy.

Primary Endpoint

Time to first recurrence of symptomatic AF; Ablation Arm: Severe (>70%) PV stenosis; Thromboembolic event with residual sequelae, TIA, pericarditis, MI, diaphragmatic paralysis, procedural complication requiring intervention & death. Antiarrythmic drug therapy Arm: Torsade de Pointes, syncope, bradycardia requiring pacemaker, other pro-arrhythmic events, any other SAEs leading to drug discontinuation. Bleeding complications assoc w/OAC therapy. Secondary Endpoints: 1. Total of symptomatic and asymptomatic AF episodes documented by TTM, 2. Quality of life at 1-year follow-up. Primary and secondary events are adjudicated.

Number of Patients

250

Number of Sites

24

Number of Countries

7

Study Period

2007–2012

Principal Investigator

Carlos Morillo, Andrea Natale

Program Manager

Ellison Themeles

Research Coordinator

Heather Beresh