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RECRUITINGINTERVENTIONAL

Cardiac Magnetic Resonance Guidance of Implantable Cardioverter Defibrillator Implantation in Non-ischemic Dilated Cardiomyopathy

Randomized Controlled, Multi-centre Trial of Cardiac Magnetic Resonance Guidance of Implantable Cardioverter Defibrillator Implantation in Non-ischemic Dilated Cardiomyopathy

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - NIDCM (idiopathic or familial)\* - LVEF ≤35% and presence of fibrosis on CMR - Diagnostic CMR scan - Age ≥18 years - Written willing to sign a consent form - Ability to give willing to sign a consent form Who Should NOT Join This Trial: - ICM \[previous myocardial infarction, previous percutaneous coronary intervention\] - 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 \[Takotsubo syndrrome, peripartum cardiomyopathy, chemotherapy induced cardiomyopathy\]. - Myocarditis - 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) - Current pacemaker or defibrillator in situ - Current indication for device therapy (e.g. secondary prophylaxis after aborted SCD) - Renal impairment defined as an eGFR \<30 milliliters - Age \<18 years - Patients presenting with pregnancy - Patients without willing to sign a consent form - Participation in another randomized trial - Life expectancy \<2 years Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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 Criteria: * ICM \[previous myocardial infarction, previous percutaneous coronary intervention\] * 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 \[Takotsubo syndrrome, peripartum cardiomyopathy, chemotherapy induced cardiomyopathy\]. * Myocarditis * 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) * Current pacemaker or defibrillator in situ * Current indication for device therapy (e.g. secondary prophylaxis after aborted SCD) * Renal impairment defined as an eGFR \<30 milliliters * Age \<18 years * Patients presenting with pregnancy * Patients without informed consent * Participation in another randomized trial * Life expectancy \<2 years

Treatments Being Tested

OTHER

ICD/CRT-D implantation

ICD/CRT-D implantation (if indicated)

Locations (1)

Universität zu Lübeck
Lübeck, Schleswig-Holstein, Germany