One Hospital ClinicalService Project
One Hospital ClinicalService Project
The One Hospital ClinicalService Project is an integrated system composed by a network of
 International Hospital Departments, a clinical data repository 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 One Hospital 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 clinical research.
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
Inclusion Criteria:

 -  Patients wearing a Medtronic market-released device or treated by a Medtronic therapy
 who have signed a patient data release and informed consent form

 Exclusion Criteria:

 -  Patients unwilling or unable to cooperate or give voluntary consent