Cardiomyopathies, Gender, Implantable Defibrillator User
Conditions
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.
Interventions
None listed
Sponsors
University of Rochester
Biotronik, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Assessment of left ventricular reverse remodeling by echocardiography at 12 months for CRT-D patients | 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 | 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 | 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 | 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 |
| Evaluation of cardiovascular and diabetes medication use and dosage during the study | 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 |
Countries
United States
Outcome results
None listed