Analysis of Both Sex and Device Specific Factors on Outcomes in Patients with Non-Ischemic Cardiomyopathy
- Conditions
- CardiomyopathiesImplantable Defibrillator UserGender
- Registration Number
- NCT03884608
- Lead Sponsor
- Biotronik, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1000
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of the combined risk of all-cause mortality and treated ventricular tachycardia (VT) or ventricular fibrillation (VF) events 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
- Secondary Outcome Measures
Name Time Method Rate of all-cause mortality 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 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 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
Comparison of the Seattle Proportional Risk Model (SPRM) predicted incidence of sudden death to the observed incidence of death 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
Rate of sudden cardiac death 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
Trial Locations
- Locations (49)
University of Washington
🇺🇸Seattle, Washington, 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
Southview Cardiovascular Associates
🇺🇸Birmingham, Alabama, United States
BayCare Medical Group Cardiology
🇺🇸Safety Harbor, Florida, 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
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
Montefiore Medical Center
🇺🇸Bronx, New York, 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
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
🇺🇸Mount Pleasant, South Carolina, United States
Cardiology Consultants
🇺🇸Spartanburg, South Carolina, United States
University of Tennessee Erlanger Cardiology
🇺🇸Chattanooga, Tennessee, United States