CardiomyopathiesBIO-LIBRANCT03884608
Analysis of Both Sex and Device Specific Factors on Outcomes in Patients with Non-Ischemic Cardiomyopathy
An observational study of Cardiomyopathies and Gender, run by Biotronik, Inc. at 49 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiomyopathies, Gender, Implantable Defibrillator User
- How many people
- 1,000 participants
- Where
- 49 sitesUnited States
- Study dates
- 9 May 2019to 19 Nov 2024
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients selected for participation should be from the investigator's general patient population according to the inclusion and exclusion criteria.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
49 sites in 1 country.
49 sites in 1 country
United States49 sites
University of Michigan
Ann Arbor, Michigan, 48109
Southview Cardiovascular Associates
Birmingham, Alabama, 35205
Saint Alphonsus Heart Care
Boise, Idaho, 83704
Massachusetts General Hospital
Boston, Massachusetts, 02114
NYP Brooklyn Methodist Hospital
Brooklyn, New York, 11215
Trinity Medical WNY
Buffalo, New York, 14215
Sanger Heart and Vascular
Charlotte, North Carolina, 28210
University of Tennessee Erlanger Cardiology
Chattanooga, Tennessee, 37403
University of Chicago
Chicago, Illinois, 60637
University of Cincinnati
Cincinnati, Ohio, 45267
Ohio State University
Columbus, Ohio, 43210
Cardiology Associates of Mobile
Fairhope, Alabama, 36532
Sanford Medical Center
Fargo, North Dakota, 58102
University of Florida
Gainesville, Florida, 32610
Cardiovascular Institute of North Colorado
Greeley, Colorado, 80631
East Carolina University Physicians
Greenville, North Carolina, 27834
Heart Rhythm Associates
Greenville, North Carolina, 27834
Upstate Cardiology
Greenville, South Carolina, 29607
Penn State Health Milton S Hershey
Hershey, Pennsylvania, 17033
University of Iowa
Iowa City, Iowa, 52242
Logan Health Research
Kalispell, Montana, 59901
Carolina Heart Specialists
Lancaster, South Carolina, 29720
Baptist Health Lexington
Lexington, Kentucky, 40503
University of Kentucky
Lexington, Kentucky, 40536
Carolina Arrhythmia Consultants
Mt. Pleasant, South Carolina, 29464
Weill Cornell Medicine
New York, New York, 10021
Lenox Hill Hospital
New York, New York, 10075
AdventHealth Orlando
Orlando, Florida, 32803
Orlando Health, Inc.
Orlando, Florida, 32806
Eisenhower Desert Cardiology
Rancho Mirage, California, 92270
University of Rochester
Rochester, New York, 14642
UC Davis Medical Center
Sacramento, California, 95817
BayCare Medical Group Cardiology
Safety Harbor, Florida, 34695
Geisinger Heart and Vascular Center
Scranton, Pennsylvania, 18510
University of Washington
Seattle, Washington, 98195
Cardiology Consultants
Spartanburg, South Carolina, 29303
Mercy Clinic Heart and Vascular
St Louis, Missouri, 63141
AdventHealth Tampa
Tampa, Florida, 33613
Montefiore Medical Center
The Bronx, New York, 10467
ProMedica Physicians Cardiology
Toledo, Ohio, 43615
Traverse Heart and Vascular
Traverse City, Michigan, 49684
Cardiology Associates Research
Tupelo, Mississippi, 38801
Westchester Medical Center
Valhalla, New York, 10595
Cardiology Associates Medical Group
Ventura, California, 93003
Cape Fear Heart Associates
Wilmington, North Carolina, 28401
Novant Health Winston Salem Cardiology
Winston-Salem, North Carolina, 27103
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
Metro Health Hospital
Wyoming, Michigan, 49519
Michigan Heart
Ypsilanti, Michigan, 48197
About this study
Official title: BIO-LIBRA Clinical Study
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.
Read the detailed description
The BIO-LIBRA Study will gather information about women and men with non-ischemic cardiomyopathy who are treated with implanted ICD and CRT-D devices from many locations across the United States. The BIO-LIBRA Study will look at the results of treatment in women and men enrollees. The two primary goals are: 1) to learn if there are differences in treatment response based on the patient's sex; and 2) to learn if there are differences in patient outcomes based on device type.
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
- Cardiomyopathies, Gender, Implantable Defibrillator User
- Medical subject headings
- Cardiomyopathies, Coitus
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years post-implant
Secondary outcomes (5)
Rate of all-cause mortality
Rate of all-cause mortality will be analyzed for the total cohort, as well as by sex and by the implanted device type
Measured: 3 years post-implant
Rate of treated ventricular tachycardia (VT) or ventricular fibrillation (VF) events
Rate of treated ventricular tachycardia (VT) or ventricular fibrillation (VF) events will be analyzed for the total cohort, as well as by sex and by the implanted device type
Measured: 3 years post-implant
Rate of cardiac death
Rate of cardiac death will be analyzed for the total cohort, as well as by sex and by the implanted device type
Measured: 3 years post-implant
Rate of sudden cardiac death
Rate of sudden cardiac death will be analyzed for the total cohort, as well as by sex and by the implanted device type
Measured: 3 years post-implant
Comparison of the Seattle Proportional Risk Model (SPRM) predicted incidence of sudden death to the observed incidence of death
Comparison of the Seattle Proportional Risk Model (SPRM) predicted incidence of sudden death to the observed incidence in this patient population
Measured: 3 years post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start9 May 2019
- Primary completion19 Nov 2024
- Study completion19 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CardiomyopathiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Biotronik, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Rochester
- Responsible party
- Sponsor
- Investigators
- Valentina Kutyifa, MD, PhD, Principal investigator, University of RochesterJeanne Poole, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03884608
- Sponsor's protocol ID
- BIO-LIBRA
- Acronym
- BIO-LIBRA
- Status last verified
- Nov 2024
- First submitted
- 18 Mar 2019
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 40697957
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIO-LIBRA Clinical Study
- ClinicalTrials.gov ID
- NCT03884608
- Acronym / sponsor ID
- BIO-LIBRA / BIO-LIBRA
- Conditions
- Cardiomyopathies, Gender, Implantable Defibrillator User
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Biotronik, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Rochester
- Study start
- 9 May 2019 (actual)
- Primary completion
- 19 Nov 2024 (actual)
- Study completion
- 19 Nov 2024 (actual)
- First posted
- 21 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The BIO-LIBRA Study will gather information about women and men with non-ischemic cardiomyopathy who are treated with implanted ICD and CRT-D devices from many locations across the United States. The BIO-LIBRA Study will look at the results of treatment in women and men enrollees. The two primary goals are: 1) to learn if there are differences in treatment response based on the patient's sex; and 2) to learn if there are differences in patient outcomes based on device type.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients selected for participation should be from the investigator's general patient population according to the inclusion and exclusion criteria.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of the combined risk of all-cause mortality and treated ventricular tachycardia (VT) or ventricular fibrillation (VF) events
Time frame: 3 years post-implant
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
5 secondary outcomes
Rate of all-cause mortality
Time frame: 3 years post-implant
Rate of treated ventricular tachycardia (VT) or ventricular fibrillation (VF) events
Time frame: 3 years post-implant
Rate of cardiac death
Time frame: 3 years post-implant
Rate of sudden cardiac death
Time frame: 3 years post-implant
Comparison of the Seattle Proportional Risk Model (SPRM) predicted incidence of sudden death to the observed incidence of death
Time frame: 3 years post-implant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Derived from this study: PubMed 40697957Kutyifa 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valentina Kutyifa, MD, PhD principal investigator
University of Rochester
Jeanne Poole, MD principal investigator
University of Washington
49 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiomyopathies and Gender, run by Biotronik, Inc. at 49 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the combined risk of all-cause mortality and treated ventricular tachycardia (VT) or ventricular fibrillation (VF) events (time frame: 3 years post-implant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03884608, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.