BIO-LIBRA Clinical Study

Status: Active, not recruiting
Location: See all (49) locations...
Study Type: Observational [Patient Registry]
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Patient meets current guideline-defined indication for de novo, primary prevention ICD or CRT-D implantation

• Patient has non-ischemic etiology of cardiomyopathy

• 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

• Patient is able to understand the nature of the study and provide informed consent

• 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

• Patient is willing to utilize BIOTRONIK Home Monitoring® via CardioMessenger

• Patient age is greater than or equal to 18 years

Locations
United States
Alabama
Southview Cardiovascular Associates
Birmingham
Cardiology Associates of Mobile
Fairhope
California
Eisenhower Desert Cardiology
Rancho Mirage
UC Davis Medical Center
Sacramento
Cardiology Associates Medical Group
Ventura
Colorado
Cardiovascular Institute of North Colorado
Greeley
Florida
University of Florida
Gainesville
AdventHealth Orlando
Orlando
Orlando Health, Inc.
Orlando
BayCare Medical Group Cardiology
Safety Harbor
AdventHealth Tampa
Tampa
Iowa
University of Iowa
Iowa City
Idaho
Saint Alphonsus Heart Care
Boise
Illinois
University of Chicago
Chicago
Kentucky
Baptist Health Lexington
Lexington
University of Kentucky
Lexington
Massachusetts
Massachusetts General Hospital
Boston
Michigan
University of Michigan
Ann Arbor
Traverse Heart and Vascular
Traverse City
Metro Health Hospital
Wyoming
Michigan Heart
Ypsilanti
Missouri
Mercy Clinic Heart and Vascular
Saint Louis
Mississippi
Cardiology Associates Research
Tupelo
Montana
Logan Health Research
Kalispell
North Carolina
Sanger Heart and Vascular
Charlotte
East Carolina University Physicians
Greenville
Heart Rhythm Associates
Greenville
Cape Fear Heart Associates
Wilmington
Novant Health Winston Salem Cardiology
Winston-salem
Wake Forest Baptist Health
Winston-salem
North Dakota
Sanford Medical Center
Fargo
New York
Montefiore Medical Center
Bronx
NYP Brooklyn Methodist Hospital
Brooklyn
Trinity Medical WNY
Buffalo
Lenox Hill Hospital
New York
Weill Cornell Medicine
New York
University of Rochester
Rochester
Westchester Medical Center
Valhalla
Ohio
University of Cincinnati
Cincinnati
Ohio State University
Columbus
ProMedica Physicians Cardiology
Toledo
Pennsylvania
Penn State Health Milton S Hershey
Hershey
Geisinger Heart and Vascular Center
Scranton
South Carolina
Upstate Cardiology
Greenville
Carolina Heart Specialists
Lancaster
Carolina Arrhythmia Consultants
Mount Pleasant
Cardiology Consultants
Spartanburg
Tennessee
University of Tennessee Erlanger Cardiology
Chattanooga
Washington
University of Washington
Seattle
Time Frame
Start Date: May 9, 2019
Estimated Completion Date: November 30, 2024
Participants
Target number of participants: 1000
Authors
Jeanne Poole, Valentina Kutyifa
Related Therapeutic Areas
Sponsors
Leads: Biotronik, Inc.
Collaborators: University of Rochester

This content was sourced from clinicaltrials.gov

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