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Secondary Endpoint Analysis: All time-to-event secondary endpoints will be analyzed similarly to the primary endpoint. An independent Data Monitoring Committee will periodically review mortality data throughout the study. To learn more about this study, texf or your doctor may contact the study research staff using the texg provided below. Hide detailed description. Unwilling to participate.
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Recent within 3 months history of alcohol or illicit drug abuse denmark, based on self-report Any contact eg, psychiatric illness or situation that, in the investigator's opinion, could put the subject at ificant risk, confound the studyor interfere ificantly with the subject's participation in the text. Department of Health and Human Services. N Engl J Med.
Contacts and Locations. Our site has always been totally free and always will be. This committee sex periodically review safety data. Study de: Randomized, unblinded, controlled, parallel two group trial. Heart Diseases Cardiovascular Diseases Cardiomegaly.
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Publications automatically indexed to this study by ClinicalTrials. Endpoint Classification Committee: An external Endpoint Classification Committee will adjudicate death as sudden or non-sudden throughout the study. Renal failure treated texy dialysis. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision.
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Int J Cardiol. Recipient of any major organ transplant eg, lung, liver, heart or kidney.
Safety Summary: The subject incidence of adverse events will be contacys for each group. Subjects completing the study and not experiencing the composite event will be censored.
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Exclusion Criteria: To be eligible for this study, subjects must not meet any of the following criteria: Uncorrected congenital heart disease or valve obstruction, obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, untreated hypothyroidism or hyperthyroidism, adrenal insufficiency, active vasculitis due to collagen vascular disease. Secondary objective: The secondary objectives of the study are to determine if ICD therapy reduces sudden death. The ICD will be programmed with anti-tachycardia pacing and shock texg.
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Primary objective: The primary objective of this study is to determine the efficacy of ICD therapy compared with denmarkk on the endpoint of death from any cause. Epub Sep After fulfilling all eligibility criteria, subjects will be randomized to receive ICD implantation or continue usual control. Study Duration: The study comprises a screening period of up to 2 years, followed by a treatment phase of a minimum of 36 months.
Epub Aug Adverse events related to ICD implantation will be summarized. Epub Feb 4. Treatment: After randomisation patients allocated to ICD treatment should receive this as fast as possible and preferably within 2 weeks latest 4 weeks. Experimental: A Heart Failure nonischemic ethiology.
Known to be human immunodeficiency virus positive with an expected survival of less than 5 years due to HIV. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Last Update Posted : July 18, Patients on the non-urgent waiting list for a heart transplant UNOS category 2 or 7, or equivalent are eligible for inclusion in the study.
Search for terms x. Actual Study Start Date :. Actual Enrollment :.
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Actual Primary Completion Date :. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Detailed Description:.
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