Status:
UNKNOWN
CarDiac MagnEtic Resonance for Primary Prevention Implantable CardioVerter DebrillAtor ThErapy: an International Registry (DERIVATE)
Lead Sponsor:
Gianluca Pontone, MD, PhD
Collaborating Sponsors:
University of Lausanne Hospitals
Conditions:
Heart Failure
Left Ventricular Systolic Dysfunction
Eligibility:
All Genders
Brief Summary
The DERIVATE study was conceived to integrate the information resulted from clinical data, transthoracic echocardiography, and cardiac magnetic resonance (CMR) imaging to provide a more reliable risk ...
Detailed Description
The current guidelines provide indications for primary prevention implanted cardioverter defibrillator (ICD) therapy based on left ventricle ejection fraction (LVEF) and New York Heart Association (NY...
Eligibility Criteria
Inclusion
- Heart Failure patients (according to the ACC/AHA classification) with known ischemic cardiomyopathy (ICM) or non ischemic dilated cardiomyopathy (DCM)
- reduced left ventricle ejection fraction (LVEF) (\<50%)
Exclusion
- pregnancy
- current alcohol or drug abuse
- unstable angina
- decompensated HF (NYHA class IV) in the previous 1 month
- acute myocarditis in the previous 3 months
- recent myocardial infarction (MI) (\<40 days) or)
- severe valvular disease
- cardiac amyloidosis
- hypertrophic cardiomyopathy
- arrhthmogenic right ventricular cardiomyopathy
- takotsubo cardiomyopathy
- congenital heart disease
- non CMR compatible device
- estimated glomerular filtration rate ≤30 mL/min/1.73m2
- other contraindication to gadolinium contrast agent
- severe claustrophobia
- participating in other trials with an active treatment arm (not to exclude patients who are in trials of diagnostic techniques or approved therapies)
- unwilling or unable to provide informed consent.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
4000 Patients enrolled
Trial Details
Trial ID
NCT03352648
Start Date
January 1 2007
End Date
December 1 2020
Last Update
June 6 2019
Active Locations (29)
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1
Loyola University of Chicago,
Chicago, Illinois, United States, 60611
2
Medical University of South Carolina
Charleston, South Carolina, United States, 29402
3
KU Leuven-University of Leuven
Leuven, Belgium, 3000
4
St.Luke's Hospital Thessaloniki
Thessaloniki, Greece, 57010