Study Type
Interventional - Drug
completed
The objective of the RAAFT study was 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 (AF) not previously treated with therapeutic doses of antiarrhythmic drugs.
Primary endpoints:
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 one-year follow-up.
Primary and secondary events are adjudicated.
Study Design
Randomized, open label, active control, parallel group design, safety/efficacy.
NO. of Countries
6
NO. of Sites
24
NO. of Participants
127
Study Period
2007-2012
Sponsor
PHRI
Ellison Themeles
Associate Program Manager
Ellison Themeles
Associate Program Manager
Ellison Themeles’ experience includes more than 20 years in the conduct, execution and management of large, international clinical trials involving both medical devices and pharmaceutical agents in the area of cardiovascular disease and arrhythmias.
She holds a Bachelor of Arts degree in Gerontology and Sociology, and a Master of Science Degree in Health Research Methodology, from McMaster University.
