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Main
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Note: This record shows only 22 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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16 December 2017 |
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Main ID: |
NCT00711893 |
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Date of registration:
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07/07/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Feature Assessment Study for Indications Based Programming
FASt-IBP |
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Scientific title:
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Feature Assessment Study for Indications Based Programming |
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Date of first enrolment:
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June 2008 |
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Target sample size:
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301 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00711893 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Austria
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Belgium
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China
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France
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Germany
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Greece
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Latvia
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Netherlands
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Slovakia
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Spain
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Switzerland
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Contacts
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Name:
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Konrad Goehl, 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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Klinikum Nuernberg |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- indicated for implantation of an ICD or CRT-D device according local hospital implant
criteria guidelines
- Implanted or intended to be implanted with any CE-marked device approved for
implant from the TELIGEN (single or dual chamber ICD) or COGNIS (CRT-D) family
during first implant (no replacements)
- Geographically stable patients who are available for follow-up at a study centre
- Age 18 or above, or of legal age to give informed consent specific to national
law
Exclusion Criteria:
Inability or refusal to sign the Patient Informed Consent
- Pregnant or planning to become pregnant
- Replacement device
- Enrolment in another clinical trial, study or evaluation
- Estimated life expectancy of less than six months per discretion of physician
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ventricular Fibrillation
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Ventricular Flutter
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Heart Failure
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Ventricular Tachycardia
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Intervention(s)
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Device: Cognis 100-D, Teligen DR and VR 100 HE
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Primary Outcome(s)
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Proportion of patients that are programmed by the physician to anything other than the recommended IBP setting
[Time Frame: 6 Months]
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Secondary Outcome(s)
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- Degree of acceptance of IBP - Proportion parameters changed per patient - Differences between recommended and final programmed parameters - Total number of parameter changes from IBP recommendations - Frequency of changes made to a single parameter
[Time Frame: 6 Months]
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Secondary ID(s)
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FASt-IBP 0408
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feci 08/1644
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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