Clinical trial NCT03884608: Analysis of Both Sex and Device Specific Factors on Outcomes in Patients with Non-Ischemic Cardiomyopathy
Official title: BIO-LIBRA Clinical Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiomyopathies
Gender
Implantable Defibrillator User
Lead sponsor: Biotronik, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Rochester
First posted: 2019-03-21
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Evaluation of the combined risk of all-cause mortality and treated ventricular tachycardia (VT) or ventricular fibrillation (VF) events
timeFrame: 3 years post-implant
Secondary outcomes:
measure: Rate of all-cause mortality
timeFrame: 3 years post-implant
measure: Rate of treated ventricular tachycardia (VT) or ventricular fibrillation (VF) events
timeFrame: 3 years post-implant
measure: Rate of cardiac death
timeFrame: 3 years post-implant
measure: Rate of sudden cardiac death
timeFrame: 3 years post-implant
measure: Comparison of the Seattle Proportional Risk Model (SPRM) predicted incidence of sudden death to the observed incidence of death
timeFrame: 3 years post-implant
Other outcomes:
measure: Evaluation of cardiovascular and diabetes medication use and dosage during the study
timeFrame: 3 years post-implant
measure: Assessment of left ventricular reverse remodeling by echocardiography at 12 months for CRT-D patients
timeFrame: 12 months post-implant
measure: Rate of inappropriate ICD therapy
timeFrame: 3 years post-implant
measure: Rate of ventricular tachycardia (VT) or ventricular fibrillation (VF) events treated with shock only
timeFrame: 3 years post-implant
measure: Rate of observed major complications
timeFrame: 3 years post-implant
Locations:
city: Birmingham
country: United States
facility: Southview Cardiovascular Associates
state: Alabama
city: Fairhope
country: United States
facility: Cardiology Associates of Mobile
state: Alabama
city: Rancho Mirage
country: United States
facility: Eisenhower Desert Cardiology
state: California
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
city: Ventura
country: United States
facility: Cardiology Associates Medical Group
state: California
city: Greeley
country: United States
facility: Cardiovascular Institute of North Colorado
state: Colorado
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Orlando
country: United States
facility: Orlando Health, Inc.
state: Florida
city: Safety Harbor
country: United States
facility: BayCare Medical Group Cardiology
state: Florida
city: Tampa
country: United States
facility: AdventHealth Tampa
state: Florida
city: Boise
country: United States
facility: Saint Alphonsus Heart Care
state: Idaho
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Traverse City
country: United States
facility: Traverse Heart and Vascular
state: Michigan
city: Wyoming
country: United States
facility: Metro Health Hospital
state: Michigan
city: Ypsilanti
country: United States
facility: Michigan Heart
state: Michigan
city: Tupelo
country: United States
facility: Cardiology Associates Research
state: Mississippi
city: St. Louis
country: United States
facility: Mercy Clinic Heart and Vascular
state: Missouri
city: Kalispell
country: United States
facility: Logan Health Research
state: Montana
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Brooklyn
country: United States
facility: NYP Brooklyn Methodist Hospital
state: New York
city: Buffalo
country: United States
facility: Trinity Medical WNY
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Valhalla
country: United States
facility: Westchester Medical Center
state: New York
city: Charlotte
country: United States
facility: Sanger Heart and Vascular
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University Physicians
state: North Carolina
city: Greenville
country: United States
facility: Heart Rhythm Associates
state: North Carolina
city: Wilmington
country: United States
facility: Cape Fear Heart Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: Novant Health Winston Salem Cardiology
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Fargo
country: United States
facility: Sanford Medical Center
state: North Dakota
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Toledo
country: United States
facility: ProMedica Physicians Cardiology
state: Ohio
city: Hershey
country: United States
facility: Penn State Health Milton S Hershey
state: Pennsylvania
city: Scranton
country: United States
facility: Geisinger Heart and Vascular Center
state: Pennsylvania
city: Greenville
country: United States
facility: Upstate Cardiology
state: South Carolina
city: Lancaster
country: United States
facility: Carolina Heart Specialists
state: South Carolina
city: Mount Pleasant
country: United States
facility: Carolina Arrhythmia Consultants
state: South Carolina
city: Spartanburg
country: United States
facility: Cardiology Consultants
state: South Carolina
city: Chattanooga
country: United States
facility: University of Tennessee Erlanger Cardiology
state: Tennessee
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Rochester
name: Valentina Kutyifa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Jeanne Poole, MD
role: PRINCIPAL_INVESTIGATOR
References: