The purpose of this study is to demonstrate the safety and efficacy of RSD1235 compared to placebo in the conversion of atrial arrhythmia to sinus rhythm in subjects following valvular and/or coronary artery bypass graft surgery.
This multi-national, multi-center study is a double blind, randomized, placebo-controlled trial with 2 parallel treatment arms (1 active, 1 placebo) to assess the conversion efficacy and safety of 2 intravenous doses of RSD1235 in subjects with atrial fibrillation or atrial flutter following valvular and/or coronary artery bypass graft (CABG) surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
190
Unnamed facility
Fort Lauderdale, Florida, United States
Unnamed facility
Atlanta, Georgia, United States
Unnamed facility
Buenos Aires, Argentina
Effectiveness of RSD1235
Time frame: 90 minutes post infusion
Proportion of patients in sinus rhythm at 90 minutes
Time frame: Time from first exposure to conversion to sinus rhythm
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Unnamed facility
La Plata, Argentina
Unnamed facility
Calgary, Alberta, Canada
Unnamed facility
Toronto, Ontario, Canada
Unnamed facility
Montreal, Quebec, Canada
Unnamed facility
Montreal, Quebec, Canada
Unnamed facility
Aalborg, DK, Denmark
Unnamed facility
Hellerup, DK, Denmark
...and 12 more locations