Tracking Information
| Start Date ICMJE | January 2005 |
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| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00382525 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE |
Descriptive Information
| Brief Title ICMJE | PANORAMA Observational Study |
|---|---|
| Official Title ICMJE | Phase IV Long Term Observational Study of Patients Implanted With Medtronic CRDM Implantable Cardiac Devices |
| Brief Summary | To construct a computerized database of national profiles and epidemiological data on patients wearing Medtronic implantable pacemakers and cardioverter defibrillators (both with or without cardiac resynchronization therapy), implantable loop recorders and leads used within their intended use. Clinical variables will be analyzed in relation to device-based data and diagnostics. |
| Detailed Description | PANORAMA will collect a large database of device behavior, for instance to monitor long term behavior of device features, technical reliability and longevity, as well as to allow studying device performance in different subgroups of patients. Larger databases are often essential for formulating and testing study hypotheses for prospective (randomized) trials. While it may depend on specific objectives for individual devices, reliable assessment of device performance over longer periods and in broad patient populations typically requires a study population from a few hundred to a few thousand patients. PANORAMA collects acute and chronic patient and device data in a large population during routine usage of the device, without specific study interventions, and always within the approved intended use of the device. In the past, observational studies were designed and conducted specifically on a device-by-device case. PANORAMA avoids the redesign of the same set of data. It establishes a core database which can be expanded with substudies creating more detailed data sets for particular CRDM devices/features. PANORAMA will be open for inclusion to any patient (to be) implanted with a CRDM device. It shall be suitable for current and upcoming CRDM devices implanted in patients. It will serve as an epidemiological tool designed to stratify morbidity and mortality of all cardiac diseases treated by implantable CRDM devices. |
| Study Phase | Phase IV |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Cohort, Prospective |
| Condition ICMJE |
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| Intervention ICMJE | Device: Cardiac Pacemaker, Defibrillator, pacemaker lead |
Recruitment Information
| Estimated Enrollment ICMJE | 10000 | ||||||||
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| Estimated Completion Date | January 2018 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | |||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Belgium, Former Serbia and Montenegro, India, Kuwait, Russian Federation, Saudi Arabia |
Administrative Information
| NCT ID ICMJE | NCT00382525 | ||||
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| Responsible Party | |||||
| Study ID Numbers ICMJE | Version 1 April 25th, 2005 | ||||
| Study Sponsor ICMJE | Medtronic Bakken Research Center | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Medtronic Bakken Research Center |