Analysis of Both Sex and Device Specific Factors on Outcomes in Patients with Non-Ischemic Cardiomyopathy
BIO-LIBRA
BIO-LIBRA Clinical Study
1 other identifier
observational
1,000
1 country
49
Brief Summary
The purpose of this registry is to prospectively assess outcomes of device-treated ventricular tachyarrhythmias and all-cause mortality in non-ischemic cardiomyopathy patients indicated for ICD or CRT-D implantation for the primary prevention of sudden cardiac death. Differences in outcomes will be evaluated by sex and by device type.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2019
Longer than P75 for all trials
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2019
CompletedFirst Posted
Study publicly available on registry
March 21, 2019
CompletedStudy Start
First participant enrolled
May 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 19, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 19, 2024
CompletedNovember 22, 2024
November 1, 2024
5.5 years
March 18, 2019
November 20, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluation of the combined risk of all-cause mortality and treated ventricular tachycardia (VT) or ventricular fibrillation (VF) events
Evaluate the combined risk of all-cause mortality and treated ventricular tachycardia (VT) or ventricular fibrillation (VF) events by sex and by implanted device type
3 years post-implant
Secondary Outcomes (5)
Rate of all-cause mortality
3 years post-implant
Rate of treated ventricular tachycardia (VT) or ventricular fibrillation (VF) events
3 years post-implant
Rate of cardiac death
3 years post-implant
Rate of sudden cardiac death
3 years post-implant
Comparison of the Seattle Proportional Risk Model (SPRM) predicted incidence of sudden death to the observed incidence of death
3 years post-implant
Other Outcomes (5)
Evaluation of cardiovascular and diabetes medication use and dosage during the study
3 years post-implant
Assessment of left ventricular reverse remodeling by echocardiography at 12 months for CRT-D patients
12 months post-implant
Rate of inappropriate ICD therapy
3 years post-implant
- +2 more other outcomes
Eligibility Criteria
Patients selected for participation should be from the investigator's general patient population according to the inclusion and exclusion criteria.
You may qualify if:
- Patient meets current guideline-defined indication for de novo, primary prevention ICD or CRT-D implantation
- Patient has non-ischemic etiology of cardiomyopathy
- 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
- Patient is able to understand the nature of the study and provide informed consent
- 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
- Patient is willing to utilize BIOTRONIK Home Monitoring® via CardioMessenger
- Patient age is greater than or equal to 18 years
You may not qualify if:
- Patient meets secondary prevention ICD indication
- Patient has ischemic etiology of cardiomyopathy
- Patient is enrolled in any investigational cardiac device or drug trial that might significantly affect the studied outcomes
- Patient is expected to receive heart transplantation or ventricular assist device within 1 year
- Patient life expectancy is less than 1 year
- Patient reports pregnancy at the time of consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biotronik, Inc.lead
- University of Rochestercollaborator
Study Sites (49)
Southview Cardiovascular Associates
Birmingham, Alabama, 35205, United States
Cardiology Associates of Mobile
Fairhope, Alabama, 36532, United States
Eisenhower Desert Cardiology
Rancho Mirage, California, 92270, United States
UC Davis Medical Center
Sacramento, California, 95817, United States
Cardiology Associates Medical Group
Ventura, California, 93003, United States
Cardiovascular Institute of North Colorado
Greeley, Colorado, 80631, United States
University of Florida
Gainesville, Florida, 32610, United States
AdventHealth Orlando
Orlando, Florida, 32803, United States
Orlando Health, Inc.
Orlando, Florida, 32806, United States
BayCare Medical Group Cardiology
Safety Harbor, Florida, 34695, United States
AdventHealth Tampa
Tampa, Florida, 33613, United States
Saint Alphonsus Heart Care
Boise, Idaho, 83704, United States
University of Chicago
Chicago, Illinois, 60637, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Baptist Health Lexington
Lexington, Kentucky, 40503, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Traverse Heart and Vascular
Traverse City, Michigan, 49684, United States
Metro Health Hospital
Wyoming, Michigan, 49519, United States
Michigan Heart
Ypsilanti, Michigan, 48197, United States
Cardiology Associates Research
Tupelo, Mississippi, 38801, United States
Mercy Clinic Heart and Vascular
St Louis, Missouri, 63141, United States
Logan Health Research
Kalispell, Montana, 59901, United States
NYP Brooklyn Methodist Hospital
Brooklyn, New York, 11215, United States
Trinity Medical WNY
Buffalo, New York, 14215, United States
Weill Cornell Medicine
New York, New York, 10021, United States
Lenox Hill Hospital
New York, New York, 10075, United States
University of Rochester
Rochester, New York, 14642, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Westchester Medical Center
Valhalla, New York, 10595, United States
Sanger Heart and Vascular
Charlotte, North Carolina, 28210, United States
East Carolina University Physicians
Greenville, North Carolina, 27834, United States
Heart Rhythm Associates
Greenville, North Carolina, 27834, United States
Cape Fear Heart Associates
Wilmington, North Carolina, 28401, United States
Novant Health Winston Salem Cardiology
Winston-Salem, North Carolina, 27103, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157, United States
Sanford Medical Center
Fargo, North Dakota, 58102, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Ohio State University
Columbus, Ohio, 43210, United States
ProMedica Physicians Cardiology
Toledo, Ohio, 43615, United States
Penn State Health Milton S Hershey
Hershey, Pennsylvania, 17033, United States
Geisinger Heart and Vascular Center
Scranton, Pennsylvania, 18510, United States
Upstate Cardiology
Greenville, South Carolina, 29607, United States
Carolina Heart Specialists
Lancaster, South Carolina, 29720, United States
Carolina Arrhythmia Consultants
Mt. Pleasant, South Carolina, 29464, United States
Cardiology Consultants
Spartanburg, South Carolina, 29303, United States
University of Tennessee Erlanger Cardiology
Chattanooga, Tennessee, 37403, United States
University of Washington
Seattle, Washington, 98195, United States
Related Publications (1)
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.
PMID: 40697957DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Valentina Kutyifa, MD, PhD
University of Rochester
- PRINCIPAL INVESTIGATOR
Jeanne Poole, MD
University of Washington
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2019
First Posted
March 21, 2019
Study Start
May 9, 2019
Primary Completion
November 19, 2024
Study Completion
November 19, 2024
Last Updated
November 22, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- The data will be available beginning no later than 12 months and ending no earlier than 3 years following publication.
- Access Criteria
- Proposals should be directed to BIOTRONIK Clinical Studies (BIOTRONIK Inc., Attn: Clinical Studies, 6024 Jean Road, Lake Oswego, OR; 1-800-547-0394). The Principal Investigator and Co-Principal Investigator, in consultation with BIOTRONIK, will review and critique subsidiary requests for scientific merit, fiscal feasibility, and logistical feasibility. They will additionally consider if the proposed publication fits into the overall BIO-LIBRA publication plan. If approved, the data requestors will need to sign a data use/access agreement prior to obtaining the data and agree to have the Principal Investigator and Co-Principal Investigator as co-authors.
De-identified participant level data collected within the study will be shared for approved requests of subsidiary studies not specifically pre-planned within the protocol.