Clinical Trials Logo

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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT03884608
Study type Observational [Patient Registry]
Source Biotronik, Inc.
Contact
Status Active, not recruiting
Phase
Start date May 9, 2019
Completion date November 30, 2024

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05428787 - Resynchronization in Patients With HF in AF Trial Undergoing Pace & AVNA Strategy With LBBAP Compared With BiV Pacing N/A
Not yet recruiting NCT05567445 - Outcome of Cardiomyopathic Adults Admission in ICU.
Completed NCT02555527 - Contrast Echocardiography Cost Effectiveness for Left Ventricular Thrombus Assessment N/A
Completed NCT00371891 - Ontario Multidetector Computed Tomographic (MDCT) Coronary Angiography Study (OMCAS) Phase 4
Recruiting NCT05552521 - Diastolic Dysfunction in Septic Shock and Cardiomyopathy Genetic Variants
Recruiting NCT04166331 - Adjunctive DobutAmine in sePtic Cardiomyopathy With Tissue Hypoperfusion Phase 3
Terminated NCT06331507 - Refinement and Assessment of New MRI Technologies for Cardiovascular Exams Using the Phillips CMR Patch N/A
Completed NCT01953523 - Safety and Clinical Outcomes Study: SVF Deployment for Orthopedic, Neurologic, Urologic, and Cardio-pulmonary Conditions N/A
Recruiting NCT04695119 - Sepsis in the ICU-II
Completed NCT03228966 - Ped HIV - Echo Study: Kenya
Not yet recruiting NCT06348732 - Diagnostic and Prognostic Role of Troponin and Brain Natriuretic Peptide in Pediatric Patients With Cardiomyopathy in Correlation to Echocardiography Findings
Recruiting NCT05556369 - Genetic Characterization of Cardiomyopathies (POLICARDIOMIO2021)
Recruiting NCT04520646 - A Pilot Study of Empagliflozin in the Treatment of Acromegalic Cardiomyopathy N/A
Not yet recruiting NCT03899298 - Safety and Clinical Outcomes With Amniotic and Umbilical Cord Tissue Therapy for Numerous Medical Conditions Phase 1
Completed NCT04323852 - Can Vitamin D Reduce Heart Muscle Damage After Bypass Surgery? Phase 4
Completed NCT03527381 - Nitric Oxide in Cardiopulmonary Bypass for Renal Protection in Cardiac Surgery Phase 1/Phase 2
Withdrawn NCT02462213 - Prospective Identification of Cardiac Amyloidosis by Cardiac Magnetic Resonance Imaging N/A
Active, not recruiting NCT00418041 - Chronic Heart Failure Analysis and Registry in the Tohoku District 2 (CHART-2 Study) N/A
Not yet recruiting NCT06091475 - Therapy to Maintain Remission in Dilated Cardiomyopathy N/A
Recruiting NCT03317964 - Genetic Basis of Pacing-induced Cardiomyopathy