A Blinded Study to Evaluate Effect on Atrial Fibrillation Burden in Patients With Paroxysmal Atrial Fibrillation
Launched by BRISTOL-MYERS SQUIBB · Jun 3, 2014
Trial Information
Current as of May 30, 2025
Terminated
Keywords
ClinConnect Summary
Primary Purpose: Protocol designed to assess, by the use of long term non-invasive beat-to-beat monitoring with the SEEQ Mobile Cardiac Telemetry (MCT) system, the effect of BMS-919373 on the percent change from baseline relative to placebo of atrial fibrillation burden in subjects with paroxysmal atrial fibrillation.
Gender
ALL
Eligibility criteria
- • For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
- Inclusion Criteria:
- • Signed informed consent
- • Paroxysmal Atrial Fibrillation (pAF) with available documentation of AF and reporting symptoms within 6 months prior to screening
- • Able to tolerate withdrawal of antiarrhythmic therapy (rhythm control)
- • Echocardiographically measured left ventricular ejection fraction (LVEF) ≥40%,measured within 12 months of enrollment
- • Echocardiographically measured left atrial (LA) diameter ≤ 5.0 cm, measured within 12 months of enrollment
- Exclusion Criteria:
- • Women of childbearing potential
- • AFB \< 3% or \> 70%, during both screening periods independently
- • Permanent or persistent Atrial Fibrillation
- • Cardioversion within 3 months of study drug administration
- • Stroke within 12 months of study drug administration
- • TIA within 12 months of study drug administration
- • Heart failure of NYHA class III or greater (symptoms of heart failure at rest or with minimal exertion)
- • Heart failure of NYHA class II (symptoms of heart failure with routine levels of exertion)with ejection fraction \<40% as measured by echocardiography at any time within 12 months of study enrollment (i.e. additional ejection fraction measurements ≥ 40% over this period will not counter this exclusion)
- • Valvular heart disease (including any valvular insufficiency or stenosis greater than"mild")
- • Ablation within 3 months of study enrollment
About Bristol Myers Squibb
Bristol-Myers Squibb (BMS) is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. With a robust portfolio of products across multiple therapeutic areas, including oncology, immunology, cardiovascular, and fibrotic diseases, BMS emphasizes cutting-edge research and a commitment to advancing medical science through clinical trials. The company is driven by a mission to provide transformative therapies, leveraging collaboration and scientific expertise to address unmet medical needs and improve patient outcomes worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Long Beach, California, United States
Tullahoma, Tennessee, United States
New Westminster, British Columbia, Canada
Newmarket, Ontario, Canada
Waterbury, Connecticut, United States
Edmonton, Alberta, Canada
Anderson, Indiana, United States
Tulsa, Oklahoma, United States
Layton, Utah, United States
Cambridge, Ontario, Canada
Oshawa, Ontario, Canada
Montreal, Quebec, Canada
Anaheim, California, United States
Quebec, , Canada
Austin, Texas, United States
Moreno Valley, California, United States
Costa Mesa, California, United States
Columbus, Georgia, United States
Greenfield Park, Quebec, Canada
Alexandria, Louisiana, United States
Camp Hill, Pennsylvania, United States
Anaheim, California, United States
Cooper City, Florida, United States
Largo, Florida, United States
Gainesville, Florida, United States
Lake Worth, Florida, United States
Overland Park, Kansas, United States
Grimsby, Ontario, Canada
London, Ontario, Canada
Oshawa, Ontario, Canada
Toronto, Ontario, Canada
Waterloo, Ontario, Canada
Terrebonne, Quebec, Canada
Patients applied
Trial Officials
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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