Interventional - Drug
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.
Time to first recurrence of symptomatic AF.
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.
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.
Interventional - Drug
Randomized, open label, active control, parallel group design, safety/efficacy.
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.
Study Team Specialist
Heather Beresh has worked at PHRI since May 2002, largely devoted to managing global, multi-centre clinical trials of antithrombotic therapies in patients with atrial fibrillation (AF). She started as research coordinator for the ACTIVE study evaluating dual antiplatelet therapy and angiotensin receptor blockers in patients with AF, then continued with oversight of the AVERROES open label extension trial evaluating a novel oral anticoagulant in the same population, and ARTESiA evaluating anticoagulant therapy in patients with subclinical AF.
After years as Associate Program Manager for the Heart Failure and Arrhythmia Program, managing networks such as C-SPIN, and on the ACT COVI-19 research program, Heather was made Study Team Specialist in 2021, to provide regulatory, country and site management expertise to the studies in the Global Health research team. She has as a Master’s degree in Medical Sciences from McMaster University.
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