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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00733590 |
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Date of registration:
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11/08/2008 |
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Primary sponsor: |
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Public title:
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Prospective Observational Study of the ICD in Sudden Cardiac Death Prevention
PROSE-ICD |
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Scientific title:
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Prospective Observational Study of the ICD in Sudden Cardiac Death Prevention (PROSE-ICD) |
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Date of first enrolment:
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June 2003 |
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Target sample size:
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1200 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00733590 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Countries of recruitment
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United States
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Contacts
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Name:
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Barbara Butcher, BSN |
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Address:
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Telephone:
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443 287-3472 |
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Email:
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bbutche1@jhmi.edu |
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Affiliation:
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Name:
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Gordon F Tomaselli, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Professor of Medicine Johns Hopkins University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- history of acute MI at least 4 weeks old
- non-ischemic LV dysfunction for at least 9 months
- who have an EF < or = to 35%
- undergone implantation of an FDA-approved ICD for primary prevention of SCD within 4
weeks of enrollment
Exclusion Criteria:
- ICD implantation for secondary prevention
- inability or unwillingness to provide valid informed consent
- women < 50 years old with anatomic child-bearing potential who are unwilling to use
contraceptives
- New York Heart Association class IV heart failure
- patients with permanent pacemakers or pre-existing Class 1 indications for pacemaker
implantation
- unsuccessful ICD implantation
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Arrhythmia
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Cardiomyopathies
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Death, Sudden, Cardiac
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Heart Failure, Congestive
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Primary Outcome(s)
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Arrhythmic Sudden Death defined as a shock from the ICD for rapid VT or VF or a ventricular arrhythmia not corrected by the ICD
[Time Frame: 3 years]
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Secondary Outcome(s)
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All cause mortality, CV mortality, heart transplant, ICD explantation
[Time Frame: total period of observation in the study]
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Secondary ID(s)
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02-12-16-06
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1RO1-HL091062-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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