Study of Personalized Allocation of Defibrillators in Non-ischemic Heart Failure (SPANISH-1)
About This Trial
Prospective, randomised, multicentre, open-label study to assess the non-inferiority of a personalised precision strategy for Sudden Cardiac Death (SCD) prevention in patients with non-ischemic dilated cardiomyopathy with Left Ventricular Ejection Fraction (LVEF) ≤35%
Who May Be Eligible (Plain English)
Original Eligibility Criteria
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Treatments Being Tested
Control Strategy
ICDs will be implanted in all patients according to current recommendations
Personalized precision ICD implantation Strategy based in genetic findings and CMR results
Patients allocated to the intervention strategy will receive an ICD according to genetic and CMR results. ICD implantation criteria in patients allocated to the personalised strategy group will be the presence of either a DCM-causing pathogenic or likely pathogenic genetic variants or LGE in CMR. Patients without DCM-associated genetic variants and without LGE on CMR will not receive standard treatment but an ICD will not be implanted on them.