Clinical trial NCT02153437: Study of the Effects of BMS-919373 on the Electrical Activity of the Heart Using Pacemakers
Official title: A Study of the Effects of BMS-919373 on Atrial Effective Refractory Period in Subjects With a Dual-Chamber Pacemaker
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Atrial Fibrillation
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2014-06-03
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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


Eligibility 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/Exclusion criteria apply.

Primary outcomes:
measure: The effect of BMS-919373 on Atrial effective refractory period (AERP) in subjects with a dual chamber pacemaker
timeFrame: At 0.5, 1, 2, and 4 hours following study drug administration
Secondary outcomes:
measure: The safety assessments will be based on Adverse event reports, vital sign measurements, Electrocardiogram (ECGs), physical examinations and clinical laboratory tests
timeFrame: At 1, 2, and 4 hours following study drug administration
measure: Safety assessments based on Ventricular Effective Refractory Period (VERP) and change from baseline
timeFrame: At 2 hour following study drug administration
measure: Safety assessments based on Atrioventricular interval (AVI) and change from baseline
timeFrame: At 1, 2, and 4 hours following study drug administration
measure: Safety assessments based on Wenckebach cycle length (WCL) and change from baseline
timeFrame: At 1, 2, and 4 hours following study drug administration
measure: Safety assessments based on Intra-atrial conduction time (IACT) and change from baseline
timeFrame: At 1, 2, and 4 hours following study drug administration
Other outcomes:
Locations:
city: Austin
country: United States
facility: Local Institution
state: Texas
city: Calgary
country: Canada
facility: The University Of Calgary
state: Alberta
city: Ottawa
country: Canada
facility: University Of Ottawa Heart Institute
state: Ontario
city: Toronto
country: Canada
facility: Local Institution - 0001
state: Ontario
city: Montreal
country: Canada
facility: Local Institution - 0002
state: Quebec
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: