Pacemaker Holter Assessment of the Effect of BMS-914392 on Atrial Fibrillation Burden

Launched by BRISTOL-MYERS SQUIBB · May 19, 2011

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Paroxysmal atrial fibrillation (AF)
• • Programmable dual chamber pacemaker with appropriate arrhythmia diagnostics.
• • 1-50% AF burden on pacemaker interrogation at screening.
• • Women of childbearing potential (WOCBP) and men must be using an acceptable method of contraception to avoid pregnancy.
• Exclusion Criteria:
• • Persistent or permanent AF.
• • AF Burden \<1% or \> 50%.
• • Current or history of neurological diseases and mental disorders.
• • Ejection Fraction \< 45%.
• • Severe mitral or aortic valve dysfunction.
• • TIA (Transient Ischemic Attack) within last 12 months.
• • Acute coronary syndrome in the last 2 months.
• • Previous AF ablation.
• • Cardioversion in last 3 months.
• • Current kidney or liver disease, or current cancer.
• • History of neurological and mental disorders.
• • Major surgery within 4 weeks of first dose (cardiac surgery within 4 months).
• • Screening lab test results outside of allowed limits per protocol.
• • QTcF \> 450 msec.