One Hospital ClinicalService Project (OHCS)
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|ClinicalTrials.gov Identifier: NCT01007474|
Recruitment Status : Recruiting
First Posted : November 4, 2009
Last Update Posted : February 20, 2020
|Condition or disease||Intervention/treatment|
|Arrhythmias, Cardiac Bradycardia Syncope||Device: Implantable Cardioverter-Defibrillator (ICD) Device: Implantable Pacemaker Generator (IPG) Device: Implantable Loop Recorder (ILR) Device: Cardiac Resynchronization Therapy-Defibrillator (CRT-D) Device: Implantable devices working as neurostimulators, stents, spinal/bone devices or other applications|
One Hospital ClinicalService is a project aiming to provide information and analysis of clinical and device data, back to the treating healthcare providers regarding their own patients, in order to help those healthcare providers improve outcomes and understanding of their patients' care or patients' management.
The mission of the One Hospital ClinicalService Project is to improve outcomes and comprehension of diagnostic and therapeutic strategies applied to patients wearing Medtronic implantable devices or treated by Medtronic therapies. One Hospital ClinicalService provides services to evaluate and improve the quality of clinical care in the International clinical practice.
One Hospital ClinicalService 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.
One Hospital ClinicalService uses a core database which can be expanded with specific data sets for particular patient populations, diseases, therapies, devices or features.
One Hospital ClinicalService, with its prospective data collection and its data management infrastructure, forms a data-bank where physicians collect patient data and from which they receive reports about clinical and device diagnostics data. Usage and understanding of diagnostics data may help physicians to optimize tailor device programming and patient therapies. This data-bank, queried by retrospective statistical analyses, may help physicians in quality improvement activities, education, research and scientific activities.
Some examples of scientific focus available through the One Hospital ClinicalService Project include:
- Describing the use of implantable devices, such as cardioverter defibrillator (ICD), pacemakers, implantable loop recorders or others in the Italian clinical practice
- Identifying predictors or clinical variables correlated with clinical outcomes or therapy response
- Evaluating and testing methods to optimize device programming and patient therapy via device diagnostics or patient reports
|Study Type :||Observational|
|Estimated Enrollment :||10000 participants|
|Official Title:||One Hospital ClinicalService Project on Patients Implanted With Medtronic Implantable Devices or Treated by Medtronic Therapies|
|Study Start Date :||January 2004|
|Estimated Primary Completion Date :||January 2028|
|Estimated Study Completion Date :||January 2030|
- Device: Implantable Cardioverter-Defibrillator (ICD)
Medtronic market-released implantable cardioverter-defibrillator
- Device: Implantable Pacemaker Generator (IPG)
Medtronic market-released implantable pacemaker generator
- Device: Implantable Loop Recorder (ILR)
Medtronic market-released implantable loop recorder
- Device: Cardiac Resynchronization Therapy-Defibrillator (CRT-D)
Medtronic market-released cardiac resynchronization therapy defibrillator
- Device: Implantable devices working as neurostimulators, stents, spinal/bone devices or other applications
Medtronic market-released implantable devices used as neurostimulators, stents, spinal/bone devices or for other applications
- Mortality [ Time Frame: 10 years ]
- Hospitalizations [ Time Frame: 10 years ]
- Device interventions [ Time Frame: 10 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01007474
|Contact: Andrea Grammaticofirstname.lastname@example.org|
|Contact: Francesco DeSetaemail@example.com|
|Study Chair:||Giuseppe Boriani, MD||Cardiology Department, Policlinico di Modena, University of Modena and Reggio Emilia|