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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03884608
Recruitment Status : Active, not recruiting
First Posted : March 21, 2019
Last Update Posted : March 14, 2022
Sponsor:
Collaborator:
University of Rochester
Information provided by (Responsible Party):
Biotronik, Inc.

Tracking Information
First Submitted Date March 18, 2019
First Posted Date March 21, 2019
Last Update Posted Date March 14, 2022
Actual Study Start Date May 9, 2019
Estimated Primary Completion Date November 30, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 19, 2019)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 19, 2019)
  • Rate of all-cause mortality [ Time Frame: 3 years post-implant ]
    Rate of all-cause mortality will be analyzed for the total cohort, as well as by sex and by the implanted device type
  • Rate of treated ventricular tachycardia (VT) or ventricular fibrillation (VF) events [ Time Frame: 3 years post-implant ]
    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
  • Rate of cardiac death [ Time Frame: 3 years post-implant ]
    Rate of cardiac death will be analyzed for the total cohort, as well as by sex and by the implanted device type
  • Rate of sudden cardiac death [ Time Frame: 3 years post-implant ]
    Rate of sudden cardiac death will be analyzed for the total cohort, as well as by sex and by the implanted device type
  • 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 ]
    Comparison of the Seattle Proportional Risk Model (SPRM) predicted incidence of sudden death to the observed incidence in this patient population
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 19, 2019)
  • Evaluation of cardiovascular and diabetes medication use and dosage during the study [ Time Frame: 3 years post-implant ]
    Evaluation of cardiovascular and diabetes medication use and dosage during the study in both ICD and CRT-D patients stratified by sex
  • Assessment of left ventricular reverse remodeling by echocardiography at 12 months for CRT-D patients [ Time Frame: 12 months post-implant ]
    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)
  • Rate of inappropriate ICD therapy [ Time Frame: 3 years post-implant ]
    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
  • Rate of ventricular tachycardia (VT) or ventricular fibrillation (VF) events treated with shock only [ Time Frame: 3 years post-implant ]
    Analysis of the rate of ventricular tachycardia (VT) or ventricular fibrillation (VF) events treated with shock only by sex and by device type
  • Rate of observed major complications [ Time Frame: 3 years post-implant ]
    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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Analysis of Both Sex and Device Specific Factors on Outcomes in Patients With Non-Ischemic Cardiomyopathy
Official Title BIO-LIBRA Clinical Study
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.
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 [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 3 Years
Biospecimen Not Provided
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.
Condition
  • Cardiomyopathies
  • Gender
  • Implantable Defibrillator User
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: March 19, 2019)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 30, 2024
Estimated Primary Completion Date November 30, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03884608
Other Study ID Numbers BIO-LIBRA
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (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.
Current Responsible Party Biotronik, Inc.
Original Responsible Party Same as current
Current Study Sponsor Biotronik, Inc.
Original Study Sponsor Same as current
Collaborators University of Rochester
Investigators
Principal Investigator: Valentina Kutyifa, MD, PhD University of Rochester
Principal Investigator: Jeanne Poole, MD University of Washington
PRS Account Biotronik, Inc.
Verification Date March 2022