Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
ARCA Biopharma, Inc.
With
Medtronic
The goal of the GENETIC-AF trial is to demonstrate the superiority of pharmacogenetically targeted bucindolol compared to metoprolol for the prevention of symptomatic atrial fibrillation or atrial flutter in a genotype-defined population with heart failure and/or reduced left ventricular ejection fraction at high risk of atrial fibrillation/atrial flutter recurrence.
Age
18–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Must weigh at least 40 kg
Possess the β1389 Arg/Arg genotype
Left Ventricular Ejection Fraction (LVEF) \< 0.50 assessed within 12 months prior to Screening
At least one episode of symptomatic paroxysmal or persistent AF within 180 days of Screening
Clinically appropriate for electrical cardioversion (ECV) if AF/AFL is present after study drug initiation
Receiving appropriate anticoagulation therapy prior to Randomization
You may not be if
NYHA Class IV symptoms at the time of Randomization
Significant fluid overload at Randomization
Permanent AF at Screening
More than two previous ECV within 6 months of Randomization or if the most recent ECV failed to produce SR
Presence of an LVAD, or likely to requirement LVAD placement within 6 months of Randomization
History of a successful atrioventricular (AV) node ablation
History of an AF/AFL ablation within 30 days of Randomization
Evidence of an appropriate firing of an implanted cardioverter-defibrillator (ICD) device for ventricular tachycardia (VT) or ventricular fibrillation (VF) within 90 days of Randomization
