Atrial Fibrillation
Conditions
Brief summary
To determine the effect of our compound (BMS-919373) on electrical activity of the heart using pacemakers.
Interventions
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria * Age 18 years to 85 years. * Eligible patients will have a dual-chamber permanent pacemaker. * Women who are not of childbearing potential.
Exclusion criteria
\- Patients with a history of Atrial Fibrillation (AF) that is either:. i) Permanent (i.e. patients are only in AF and never in sinus rhythm) or. ii) Persistent (i.e. patients who's episodes of AF are longer than 7 days and require medical intervention, such as electrical or medical cardioversion, to return to sinus rhythm), are excluded. * History of Transient Ischemic Attack (TIA) or stroke in the last 12 months. * History of clinically significant ventricular arrhythmia (not including isolated monomorphic Premature Ventricular Contractions (PVCs)). Such arrhythmias are marked by loss of consciousness, emergent cardioversion or defibrillation or unstable vital signs requiring medical intervention. * Complete heart block. * Planned surgery, endovascular intervention or cardioversion within the study period. * History of atrial fibrillation. * Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effect of BMS-919373 on Atrial effective refractory period (AERP) in subjects with a dual chamber pacemaker | At 0.5, 1, 2, and 4 hours following study drug administration |
Secondary
| Measure | Time frame |
|---|---|
| The safety assessments will be based on Adverse event reports, vital sign measurements, Electrocardiogram (ECGs), physical examinations and clinical laboratory tests | At 1, 2, and 4 hours following study drug administration |
| Safety assessments based on Ventricular Effective Refractory Period (VERP) and change from baseline | At 2 hour following study drug administration |
| Safety assessments based on Atrioventricular interval (AVI) and change from baseline | At 1, 2, and 4 hours following study drug administration |
| Safety assessments based on Wenckebach cycle length (WCL) and change from baseline | At 1, 2, and 4 hours following study drug administration |
| Safety assessments based on Intra-atrial conduction time (IACT) and change from baseline | At 1, 2, and 4 hours following study drug administration |
Countries
Canada, United States
Outcome results
None listed