Medtronic Observational Study in the "Real World" of Implantable Electronic Cardiac Devices (OBSERVE)
|ClinicalTrials.gov Identifier: NCT01189630|
Recruitment Status : Unknown
Verified March 2011 by Medtronic Comercial Ltda..
Recruitment status was: Enrolling by invitation
First Posted : August 26, 2010
Last Update Posted : March 30, 2011
The Observational Study in the "Real World" of Implantable Electronic Cardiac Devices will enable the construction of an electronic database with local access to clinical information, which will collect and disseminate epidemiologic data on demography, cardiovascular mortality and morbidity, and potential risk factors for a selected group of patients. These clinical variables will be analyzed against the data, as based in the programming of devices and the diagnostics. Approved descriptive statistics and analyses will be made available via Internet. The study will describe statistical indexes on sub-groups representing more than 10% of total of datasets.
The study will be open to include any patient that had a Medtronic electronic device implanted, pacemakers, ICD, ICD with CRP. The study will be also adapted for devices implanted in the present and for devices to be implanted in patients in the future.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||3500 participants|
|Official Title:||Medtronic Observational Study in the "Real World" of Implantable Electronic Cardiac Devices|
|Study Start Date :||December 2010|
|Estimated Study Completion Date :||December 2015|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01189630
|São Paulo, SP, Brazil, 04534000|
|Study Director:||Roberto Takeda, MD||Medtronic Comercial|