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

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb

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.