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Miguel Servet","Zaragoza","50009",{"type":60,"coordinates":388},[389,390],-0.87734,41.65606,{"lat":390,"lon":389},[393],{"name":394,"role":30,"phone":11,"phoneExt":11,"email":11},"Maria del Rosario Ortas Nadal",{"type":396,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[398],{"name":399,"class":6},"Instituto de Salud Carlos III","100520356","study-of-personalized-allocation-of-defibrillators-in-non-ischemic-heart-failure-spanish-1-100520356",false,"NCT06055504","Study of Personalized Allocation of Defibrillators in Non-ischemic Heart Failure (SPANISH-1)","Inclusion Criteria:\n\n* Age ≥ 18 years at the time of screening.\n* Previously established diagnosis of Non-ischemic DCM\n* Optimised medical treatment at maximum tolerated doses for at least 3 months prior to the screening date.\n* NYHA functional class II-III.\n* LVEF ≤ 35% documented by CMR as study procedure.\n* Life expectancy greater than 12 months.\n\nExclusion Criteria:\n\n* History of coronary artery disease justifying the presence of ventricular dysfunction, defined as: history of coronary revascularisation or presence of significant coronary stenosis (≥50% in left main or ≥70% in a major epicardial artery) on invasive or non-invasive coronary angiography (coronary CT)\n* Left ventricular dysfunction attributed to congenital heart disease, valvular disease, alcohol abuse or chemotherapy.\n* Hypertrophic or infiltrative cardiomyopathy, active myocarditis or constrictive pericarditis.\n* History of recovered sudden death or sustained ventricular tachycardia.\n* NYHA functional class IV.\n* Waiting list for cardiac transplantation in emergency 0.\n* Receiver of a solid organ transplant (lung, liver, heart or kidney).","ALL","18 Years",{"count":409,"type":410},900,"ESTIMATED","INTERVENTIONAL",[413],"NA","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%",[416],"Non-ischemic Dilated Cardiomyopathy","2024-02-26",{"date":419,"type":420},"2024-02-28","ACTUAL",{"date":422,"type":420},"2023-09-06",{"date":424,"type":410},"2027-10-01",{"name":5,"class":6},31]