One Hospital ClinicalService Project

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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One Hospital ClinicalService Project on Patients Implanted With Medtronic Implantable Devices or Treated by Medtronic Therapies

Conditions
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Arrhythmias, Cardiac, Bradycardia, Syncope

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalizations |  | 10 years |