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Cardiovascular Magnetic Resonance GUIDEd Insertion of Implantable Cardiac Defibrillator in Dilated CardioMyopathy
Sponsor: Flinders University
Summary
CMR GUIDE DCM is a randomized controlled trial with a registry for non-randomized patients. Patients enrolled will have non-ischemic cardiomyopathy (NICM) with mild to severe Left Ventricular (LV) systolic dysfunction with replacement fibrosis identified on Cardiac Magnetic Resonance (CMR). 954 patients will be randomised from 50 sites across 4-6 countries worldwide to receive an implantable defibrillator (ICD) or implantable loop recorder (ILR). Device and clinical follow-up will be performed at 3, 6, 12, 24, 36 months and at end of study.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1880
Start Date
2020-06
Completion Date
2026-06
Last Updated
2019-06-21
Healthy Volunteers
No
Interventions
ICD
Insertion of ICD in patients with LVEF \<45% and LGE on CMR.
ILR
Insertion of ILR in patients with LVEF \<45% and LGE on CMR.