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Cardiovascular Magnetic Resonance GUIDEd Insertion of Implantable Cardiac Defibrillator in Dilated CardioMyopathy

NCT03993730 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1880

Last updated 2019-06-21

No results posted yet for this study

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.

Conditions

  • Dilated Cardiomyopathy
  • Left Ventricular Systolic Dysfunction
  • Fibrosis Myocardial

Interventions

DEVICE

ICD

Insertion of ICD in patients with LVEF \<45% and LGE on CMR.

DEVICE

ILR

Insertion of ILR in patients with LVEF \<45% and LGE on CMR.

Sponsors & Collaborators

  • Flinders University

    lead OTHER

Principal Investigators

  • Joseph B Selvanayagam, MBBS · Flinders Medical Centre

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-30
Primary Completion
2026-06-30
Completion
2026-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03993730 on ClinicalTrials.gov