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

Randomized, Double-Blind, Placebo-Controlled, 4-Way Crossover Study to Evaluate the Safety, Tolerability and Effect on Atrial Fibrillation Burden of BMS-914392 in Patients With Paroxysmal Atrial Fibrillation and Permanent Pacemaker

The purpose of the study is to determine whether treatment with BMS-914392 is safe, well tolerated and associated with a reduction of atrial fibrillation burden in patients with paroxysmal atrial fibrillation and permanent pacemaker.

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.