Cardiac Magnetic Resonance Guidance of Implantable Cardioverter Defibrillator Implantation in Non-ischemic Dilated Cardiomyopathy
Key facts
- Where
- Lübeck, GermanySee the site
Where in Germany
- Universität zu LübeckLübeck, GermanyContact: Ingo Eitel, Prof. Dr. med.Taking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Prof. Dr. med. Ingo Eitel
- Trial code
- NCT04558723
- Record updated
- 13 May 2024
- Original description
Patients with diagnostic CMR images for assessment of LGE/fibrosis and evidence/presence of non-ischaemic myocardial fibrosis/scar will be randomized to the following treatment groups in a 1:1 ratio: ICD group or Optimal HF care group.Read full original descriptionShow less
Randomized Controlled, Multi-centre Trial of Cardiac Magnetic Resonance Guidance of Implantable Cardioverter Defibrillator Implantation in Non-ischemic Dilated Cardiomyopathy
Patients with diagnostic CMR images for assessment of LGE/fibrosis and evidence/presence of non-ischaemic myocardial fibrosis/scar will be randomized to the following treatment groups in a 1:1 ratio: ICD group or Optimal HF care group.
Inclusion: NIDCM (idiopathic or familial)*; LVEF ≤35% and presence of fibrosis on CMR; Diagnostic CMR scan; Age ≥18 years; Written informed consent; Ability to give informed consent.
Exclusion: ICM [previous myocardial infarction, previous percutaneous coronary intervention]; Current indication for device therapy (e.g. secondary prophylaxis after aborted SCD); Other cardiomyopathies (hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, infiltrative cardiomyopathies [e.g. cardiac amyloidosis, cardiac sarcoidosis, hemochromatosis and iron overload cardiomyopathy], left ventricular non-compaction cardiomyopathy, reversible cardiomyopathies [Takotsubo syndrrome, peripartum cardiomyopathy, chemotherapy induced cardiomyopathy]; Contraindication for CMR at study entry (including severe claustrophobia, pacemaker or ICD, metallic cerebral or intracranial implants, known allergy to gadolinium); Severe renal insufficiency (creatinine clearance <30 mL/min); Renal impairment defined as an eGFR <30 milliliters; Age <18 years; Life expectancy <2 years; Myocarditis; Current pacemaker or defibrillator in situ; Patients presenting with pregnancy; Patients without informed consent; Participation in another randomized trial.