Overview

Study of the Effects of BMS-919373 on the Electrical Activity of the Heart Using Pacemakers

Status:
Terminated

Trial end date:
2016-10-01

Target enrollment:
0

Participant gender:
All

Summary

To determine the effect of our compound (BMS-919373) on electrical activity of the heart using pacemakers.

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Bristol-Myers Squibb

Treatments:

Sotalol

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