Analysis of Both Sex and Device Specific Factors on Outcomes in Patients with Non-Ischemic Cardiomyopathy

Completed

• Conditions: Cardiomyopathies; Implantable Defibrillator User; Gender

• 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.

Study Timeline

• Study First Submitted: 2019-03-18
• Study First Submitted QC: 2019-03-19
• Study First Posted: 2019-03-21
• Study Start: 2019-05-09
• Status Verified: 2024-11
• Primary Completion: 2024-11-19
• Study Completion: 2024-11-19
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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 & 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)

Southview Cardiovascular Associates; 🇺🇸 Birmingham, Alabama, 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

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

BayCare Medical Group Cardiology; 🇺🇸 Safety Harbor, Florida, United States

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