Analysis of Both Sex and Device Specific Factors on Outcomes in Patients With Non-Ischemic Cardiomyopathy (BIO-LIBRA)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiomyopathies; Implantable Defibrillator User; Gender

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 Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Southview Cardiovascular Associates
    • Fairhope, Alabama, United States, 36532
      • Cardiology Associates of Mobile
  • California
    • Rancho Mirage, California, United States, 92270
      • Eisenhower Desert Cardiology
    • Sacramento, California, United States, 95817
      • UC Davis Medical Center
    • Ventura, California, United States, 93003
      • Cardiology Associates Medical Group
  • Colorado
    • Greeley, Colorado, United States, 80631
      • Cardiovascular Institute of North Colorado
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida
    • Orlando, Florida, United States, 32803
      • AdventHealth Orlando
    • Orlando, Florida, United States, 32806
      • Orlando Health, Inc.
    • Safety Harbor, Florida, United States, 34695
      • BayCare Medical Group Cardiology
    • Tampa, Florida, United States, 33613
      • AdventHealth Tampa
  • Idaho
    • Boise, Idaho, United States, 83704
      • Saint Alphonsus Heart Care
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky
    • Lexington, Kentucky, United States, 40503
      • Baptist Health Lexington
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Traverse City, Michigan, United States, 49684
      • Traverse Heart and Vascular
    • Wyoming, Michigan, United States, 49519
      • Metro Health Hospital
    • Ypsilanti, Michigan, United States, 48197
      • Michigan Heart
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • Cardiology Associates Research
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Mercy Clinic Heart and Vascular
  • Montana
    • Kalispell, Montana, United States, 59901
      • Logan Health Research
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • Brooklyn, New York, United States, 11215
      • NYP Brooklyn Methodist Hospital
    • Buffalo, New York, United States, 14215
      • Trinity Medical WNY
    • New York, New York, United States, 10021
      • Weill Cornell Medicine
    • New York, New York, United States, 10075
      • Lenox Hill Hospital
    • Rochester, New York, United States, 14642
      • University of Rochester
    • Valhalla, New York, United States, 10595
      • Westchester Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • Sanger Heart and Vascular
    • Greenville, North Carolina, United States, 27834
      • East Carolina University Physicians
    • Greenville, North Carolina, United States, 27834
      • Heart Rhythm Associates
    • Wilmington, North Carolina, United States, 28401
      • Cape Fear Heart Associates
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Health
    • Winston-Salem, North Carolina, United States, 27103
      • Novant Health Winston Salem Cardiology
  • North Dakota
    • Fargo, North Dakota, United States, 58102
      • Sanford Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati
    • Columbus, Ohio, United States, 43210
      • Ohio State University
    • Toledo, Ohio, United States, 43615
      • ProMedica Physicians Cardiology
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Health Milton S Hershey
    • Scranton, Pennsylvania, United States, 18510
      • Geisinger Heart and Vascular Center
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • Upstate Cardiology
    • Lancaster, South Carolina, United States, 29720
      • Carolina Heart Specialists
    • Mount Pleasant, South Carolina, United States, 29464
      • Carolina Arrhythmia Consultants
    • Spartanburg, South Carolina, United States, 29303
      • Cardiology Consultants
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • University of Tennessee Erlanger Cardiology
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients selected for participation should be from the investigator's general patient population according to the inclusion and exclusion criteria.

Description

Inclusion Criteria:

1. Patient meets current guideline-defined indication for de novo, primary prevention ICD or CRT-D implantation
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:

1. Patient meets secondary prevention ICD indication
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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	3 years post-implant

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of cardiovascular and diabetes medication use and dosage during the study	Evaluation of cardiovascular and diabetes medication use and dosage during the study in both ICD and CRT-D patients stratified by sex	3 years post-implant
Assessment of left ventricular reverse remodeling by echocardiography at 12 months for CRT-D patients	Assessment of left ventricular reverse remodeling using echocardiography at 12 months for patients implanted with CRT-D as characterized by the change compared to the baseline assessment of the left ventricular ejection fraction (LVEF) and left ventricular end-systolic volume (LVESV)	12 months post-implant
Rate of inappropriate ICD therapy	Analysis of the rate of inappropriate ICD therapy (ICD delivered ATP or shock for rhythms other than VT/VF) in both ICD and CRT-D patients stratified by sex	3 years post-implant
Rate of ventricular tachycardia (VT) or ventricular fibrillation (VF) events treated with shock only	Analysis of the rate of ventricular tachycardia (VT) or ventricular fibrillation (VF) events treated with shock only by sex and by device type	3 years post-implant
Rate of observed major complications	Evaluation of the observed major complication rates, including the overall rate and rates of individual major complications in both ICD and CRT-D patients stratified by sex	3 years post-implant

Collaborators and Investigators

• Sponsor: Biotronik, Inc.
• Collaborators: University of Rochester
• Investigators: Principal Investigator: Valentina Kutyifa, MD, PhD, University of Rochester; Principal Investigator: Jeanne Poole, MD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2019
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: March 18, 2019
• First Submitted That Met QC Criteria: March 19, 2019
• First Posted (Actual): March 21, 2019

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiomyopathies
• Other Study ID Numbers: BIO-LIBRA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: The data will be available beginning no later than 12 months and ending no earlier than 3 years following publication.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No