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

Cardiomyopathies Clinical Trial

— BIO-LIBRA  

Official title:

BIO-LIBRA Clinical Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03884608
• Other study ID #: BIO-LIBRA
• Status: Active, not recruiting
• Start date: May 9, 2019
• Est. completion date: November 30, 2024

Study information

• Verified date: March 2024
• Source: Biotronik, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Gender
• Implantable Defibrillator User

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Southview Cardiovascular Associates	Birmingham	Alabama
United States	Saint Alphonsus Heart Care	Boise	Idaho
United States	Massachusetts General Hospital	Boston	Massachusetts
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	Sanger Heart and Vascular	Charlotte	North Carolina
United States	University of Tennessee Erlanger Cardiology	Chattanooga	Tennessee
United States	University of Chicago	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	Ohio State University	Columbus	Ohio
United States	Cardiology Associates of Mobile	Fairhope	Alabama
United States	Sanford Medical Center	Fargo	North Dakota
United States	University of Florida	Gainesville	Florida
United States	Cardiovascular Institute of North Colorado	Greeley	Colorado
United States	East Carolina University Physicians	Greenville	North Carolina
United States	Heart Rhythm Associates	Greenville	North Carolina
United States	Upstate Cardiology	Greenville	South Carolina
United States	Penn State Health Milton S Hershey	Hershey	Pennsylvania
United States	University of Iowa	Iowa City	Iowa
United States	Logan Health Research	Kalispell	Montana
United States	Carolina Heart Specialists	Lancaster	South Carolina
United States	Baptist Health Lexington	Lexington	Kentucky
United States	University of Kentucky	Lexington	Kentucky
United States	Carolina Arrhythmia Consultants	Mount Pleasant	South Carolina
United States	Lenox Hill Hospital	New York	New York
United States	Weill Cornell Medicine	New York	New York
United States	AdventHealth Orlando	Orlando	Florida
United States	Orlando Health, Inc.	Orlando	Florida
United States	Eisenhower Desert Cardiology	Rancho Mirage	California
United States	University of Rochester	Rochester	New York
United States	UC Davis Medical Center	Sacramento	California
United States	BayCare Medical Group Cardiology	Safety Harbor	Florida
United States	Mercy Clinic Heart and Vascular	Saint Louis	Missouri
United States	Geisinger Heart and Vascular Center	Scranton	Pennsylvania
United States	University of Washington	Seattle	Washington
United States	Cardiology Consultants	Spartanburg	South Carolina
United States	AdventHealth Tampa	Tampa	Florida
United States	ProMedica Physicians Cardiology	Toledo	Ohio
United States	Traverse Heart and Vascular	Traverse City	Michigan
United States	Cardiology Associates Research	Tupelo	Mississippi
United States	Westchester Medical Center	Valhalla	New York
United States	Cardiology Associates Medical Group	Ventura	California
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	Metro Health Hospital	Wyoming	Michigan
United States	Michigan Heart	Ypsilanti	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Biotronik, Inc.	University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluation of cardiovascular and diabetes medication use and dosage during the study	Evaluation of cardiovascular and diabetes medication use and dosage during the study in both ICD and CRT-D patients stratified by sex	3 years post-implant
Other	Assessment of left ventricular reverse remodeling by echocardiography at 12 months for CRT-D patients	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)	12 months post-implant
Other	Rate of inappropriate ICD therapy	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	3 years post-implant
Other	Rate of ventricular tachycardia (VT) or ventricular fibrillation (VF) events treated with shock only	Analysis of the rate of ventricular tachycardia (VT) or ventricular fibrillation (VF) events treated with shock only by sex and by device type	3 years post-implant
Other	Rate of observed major complications	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	3 years post-implant
Primary	Evaluation of the combined risk of all-cause mortality and treated ventricular tachycardia (VT) or ventricular fibrillation (VF) events	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	3 years post-implant
Secondary	Rate of all-cause mortality	Rate of all-cause mortality will be analyzed for the total cohort, as well as by sex and by the implanted device type	3 years post-implant
Secondary	Rate of treated ventricular tachycardia (VT) or ventricular fibrillation (VF) events	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	3 years post-implant
Secondary	Rate of cardiac death	Rate of cardiac death will be analyzed for the total cohort, as well as by sex and by the implanted device type	3 years post-implant
Secondary	Rate of sudden cardiac death	Rate of sudden cardiac death will be analyzed for the total cohort, as well as by sex and by the implanted device type	3 years post-implant
Secondary	Comparison of the Seattle Proportional Risk Model (SPRM) predicted incidence of sudden death to the observed incidence of death	Comparison of the Seattle Proportional Risk Model (SPRM) predicted incidence of sudden death to the observed incidence in this patient population	3 years post-implant