Last updated on April 2018

Italian ClinicalService Project


Brief description of study

The Italian ClinicalService Project is an integrated system composed by a network of Italian hospital departments (for example cardiology departments), a clinical data repository (for example, cardiovascular data) and a shared environment for the collection, management, analysis and reporting of clinical and diagnostics data from patients treated by Medtronic therapies or patients wearing Medtronic implantable devices used within their intended use. The Italian ClinicalService is composed by a suite of systematic, data-guided activities designed to bring about immediate improvements in health delivery in particular settings. Data are prospectively collected. An independent committee of physicians prospectively identifies key clinical questions on a yearly basis for development of quality improvement activities, analyses and publications. A charter, approved by Hospital Istitutional Review Boards or other Hospital entities, assigns the ownership of data to the centers and governs the conduct of the project and the relationship of the scientific committee and Medtronic. Hospital is the data controller, while Medtronic is the data processor on behalf of the Hospital. Data collected for quality improvement purposes may be mined to perform observational research.

Detailed Study Description

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 Italian 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. ClinicalService provides services to evaluate and improve the quality of clinical care in the Italian clinical practice.

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.

ClinicalService uses a core database which can be expanded with specific data sets for particular patient populations, diseases, therapies, devices or features.

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 Italian 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

Clinical Study Identifier: NCT01007474

Contact Investigators or Research Sites near you

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Carlo Menozzi, MD

Arcispedale Santa Maria Nuova
Reggio Emilia, Italy
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Recruitment Status: Open


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