Cardiovascular Magnetic Resonance GUIDEd Insertion of Implantable Cardiac Defibrillator in Dilated CardioMyopathy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFlinders University
About this trial
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.
Eligibility criteria
Qualifiers
Age greater than/equal to 18 years old
Non-ischemic cardiomyopathy of dilated type
Left Ventricular Ejection Fraction < 45%
Able and willing to comply with all pre, post and follow-up testing and requirements
Disqualifiers
Known coronary artery disease (CAD) (History of Myocardial Infarction or Significant Epicardial CAD on Angiography)
Hypertrophic Cardiomyopathy
Cardiomyopathy related to sarcoidosis
Arrhythmogenic Right Ventricular Dysplasia
Trial design
Treatments tested in this trial
- ICD
- ILR
Treatment groups
1,880 Participants
are divided into 2 treatment groupsLocations
This trial has no locations
Sponsors and collaborators
Flinders University
Lead sponsor
Source ClinicalTrials.gov