MODULA Modul 5 BEAT-HF
This study has been completed.
Sponsor:
Guidant Corporation
Information provided by:
Guidant Corporation
ClinicalTrials.gov Identifier:
NCT00273091
First received: January 5, 2006
Last updated: April 22, 2009
Last verified: April 2009
| Tracking Information | |||||
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| First Received Date ICMJE | January 5, 2006 | ||||
| Last Updated Date | April 22, 2009 | ||||
| Start Date ICMJE | August 2003 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00273091 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | MODULA Modul 5 BEAT-HF | ||||
| Official Title ICMJE | MODULA-Study: Modul 5 / BEAT HF: Detektion and Registration of Atrial Tachyarrhythmias at Patients With Heart Failure | ||||
| Brief Summary | Detektion and Registration of Atrial Tachyarrhythmias at Patients with Heart Failure; What proportion of patients with CRT-therapy are affected at least temporarily by Atrial Arrhythmia? |
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| Detailed Description | How many patients with CRT-therapy are affected at least temporarily by Atrial Arrhythmia in terms of rate, characteristics and severity of atrial rhythm disturbances at patients with CRT-therapy within 12 months after implantation of a CRT-device. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Elegible patients comprise the investiagators standard CRT-D population. |
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| Condition ICMJE | Heart Failure | ||||
| Intervention ICMJE | Device: ICD with CRT therapy
permanently CRT pacing |
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| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Completion Date | May 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00273091 | ||||
| Other Study ID Numbers ICMJE | Version vom 10.07.2003 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | jens goetzke, guidant germany a boston scientific company | ||||
| Study Sponsor ICMJE | Guidant Corporation | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Guidant Corporation | ||||
| Verification Date | April 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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