Analysis of Both Sex and Device Specific Factors on Outcomes in Patients with Non-Ischemic Cardiomyopathy
NCT ID: NCT03884608
Last Updated: 2024-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1000 participants
OBSERVATIONAL
2019-05-09
2024-11-19
Brief Summary
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Detailed Description
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There is a special focus on women in the BIO-LIBRA Study. Usually, only about 25% of people in prior device studies have been women. Yet heart disease is the number-one cause of death for women - one in three deaths each year. The BIO-LIBRA Study would like to have a more balanced study which includes more women than in prior studies. The goal is for at least 40% of the people participating in the study to be women.
The study will observe up to 1,000 women and men over a three-year period following the device implant. Utilizing information collected at annual doctor visits and scheduled transmission reports from the implanted device in between these visits, the BIO-LIBRA Study will be able to evaluate some of the common risks of non-ischemic cardiomyopathy.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. Patient has non-ischemic etiology of cardiomyopathy
3. Patient is successfully implanted with a de novo BIOTRONIK ICD or CRT-D device and commercially available leads no more than 30 days prior to consent or is scheduled for de novo implantation of a BIOTRONIK ICD or CRT-D device no more than 30 days post consent
4. Patient is able to understand the nature of the study and provide informed consent
5. Patient is available for standard of care follow-up visits to occur at least yearly at the study site for to the expected 3 years of follow-up
6. Patient is willing to utilize BIOTRONIK Home Monitoring® via CardioMessenger
7. Patient age is greater than or equal to 18 years
Exclusion Criteria
2. Patient has ischemic etiology of cardiomyopathy
3. Patient is enrolled in any investigational cardiac device or drug trial that might significantly affect the studied outcomes
4. Patient is expected to receive heart transplantation or ventricular assist device within 1 year
5. Patient life expectancy is less than 1 year
6. Patient reports pregnancy at the time of consent
18 Years
ALL
No
Sponsors
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University of Rochester
OTHER
Biotronik, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Valentina Kutyifa, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
Jeanne Poole, MD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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Southview Cardiovascular Associates
Birmingham, Alabama, United States
Cardiology Associates of Mobile
Fairhope, Alabama, United States
Eisenhower Desert Cardiology
Rancho Mirage, California, United States
UC Davis Medical Center
Sacramento, California, United States
Cardiology Associates Medical Group
Ventura, California, United States
Cardiovascular Institute of North Colorado
Greeley, Colorado, United States
University of Florida
Gainesville, Florida, United States
AdventHealth Orlando
Orlando, Florida, United States
Orlando Health, Inc.
Orlando, Florida, United States
BayCare Medical Group Cardiology
Safety Harbor, Florida, United States
AdventHealth Tampa
Tampa, Florida, United States
Saint Alphonsus Heart Care
Boise, Idaho, United States
University of Chicago
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
Baptist Health Lexington
Lexington, Kentucky, United States
University of Kentucky
Lexington, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Traverse Heart and Vascular
Traverse City, Michigan, United States
Metro Health Hospital
Wyoming, Michigan, United States
Michigan Heart
Ypsilanti, Michigan, United States
Cardiology Associates Research
Tupelo, Mississippi, United States
Mercy Clinic Heart and Vascular
St Louis, Missouri, United States
Logan Health Research
Kalispell, Montana, United States
NYP Brooklyn Methodist Hospital
Brooklyn, New York, United States
Trinity Medical WNY
Buffalo, New York, United States
Weill Cornell Medicine
New York, New York, United States
Lenox Hill Hospital
New York, New York, United States
University of Rochester
Rochester, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Westchester Medical Center
Valhalla, New York, United States
Sanger Heart and Vascular
Charlotte, North Carolina, United States
East Carolina University Physicians
Greenville, North Carolina, United States
Heart Rhythm Associates
Greenville, North Carolina, United States
Cape Fear Heart Associates
Wilmington, North Carolina, United States
Novant Health Winston Salem Cardiology
Winston-Salem, North Carolina, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
Sanford Medical Center
Fargo, North Dakota, United States
University of Cincinnati
Cincinnati, Ohio, United States
Ohio State University
Columbus, Ohio, United States
ProMedica Physicians Cardiology
Toledo, Ohio, United States
Penn State Health Milton S Hershey
Hershey, Pennsylvania, United States
Geisinger Heart and Vascular Center
Scranton, Pennsylvania, United States
Upstate Cardiology
Greenville, South Carolina, United States
Carolina Heart Specialists
Lancaster, South Carolina, United States
Carolina Arrhythmia Consultants
Mt. Pleasant, South Carolina, United States
Cardiology Consultants
Spartanburg, South Carolina, United States
University of Tennessee Erlanger Cardiology
Chattanooga, Tennessee, United States
University of Washington
Seattle, Washington, United States
Countries
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References
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Kutyifa V, Di Biase L, Prasad KV, Torres V, Hesselson A, McCotter CJ, Harris G, Cox K, Schleede S, Heist EK, McNitt S, Brown MW, Miller C, Beck CA, Poole J; BIO-LIBRA Investigators. Contemporary medical therapy, sex-specific characteristics, and outcomes of patients with non-ischemic cardiomyopathy: a prespecified interim analysis of the BIO-LIBRA study. EClinicalMedicine. 2025 Jul 13;86:103337. doi: 10.1016/j.eclinm.2025.103337. eCollection 2025 Aug.
Other Identifiers
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BIO-LIBRA
Identifier Type: -
Identifier Source: org_study_id
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