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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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4 March 2013 |
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Main ID: |
NCT01230073 |
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Date of registration:
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26/10/2010 |
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Primary sponsor: |
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Public title:
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Treatment Satisfaction in Implantable Cardioverter Defibrillator Recipients
SAN REMO 2 |
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Scientific title:
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Treatment Satisfaction With Remote Monitoring in Implantable Cardioverter Defibrillator Recipients |
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Date of first enrolment:
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February 2011 |
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Target sample size:
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120 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01230073 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Germany
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Contacts
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Name:
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Kolb Christof |
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Address:
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Telephone:
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Email:
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Affiliation:
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Deutsches Herzzentrum |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- ICD indication according to current national or international guidelines
- Patient available for follow-up during study period
Exclusion Criteria:
- Clinically unstable medical conditions that require regular outpatient clinic
follow-up
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Improvement of Treatment Satisfaction
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Intervention(s)
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Device: Follow-up by Home-Monitoring
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Device: Home-Monitoring
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Primary Outcome(s)
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Treatment satisfaction with ICD therapy and follow-up
[Time Frame: 12 months]
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Secondary Outcome(s)
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Number of healthcare consultations
[Time Frame: 12 months]
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Secondary ID(s)
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GER-EP-004
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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