One Hospital ClinicalService Project
- Conditions
- BradycardiaArrhythmias, CardiacSyncope
- Registration Number
- NCT01007474
- Lead Sponsor
- Medtronic Italia
- Brief Summary
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
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
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Patients wearing a Medtronic market-released device or treated by a Medtronic therapy who have signed a patient data release and informed consent form
- Patients unwilling or unable to cooperate or give voluntary consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mortality 10 years
- Secondary Outcome Measures
Name Time Method Hospitalizations 10 years
Trial Locations
- Locations (41)
Stauferklinikum Mutlangen
🇩🇪Mutlangen, Germany
Landspitali University Hospital
🇮🇸Reykjavík, Iceland
Eternal Hospital
🇮🇳Jaipur, India
Fortis Escort Heart Institute
🇮🇳New Delhi, India
S.Orsola Malpigli
🇮🇹Bologna, Italy
Ospedale Civile di Bolzano
🇮🇹Bolzano, Italy
A.O. S.Sebastiano di Caserta
🇮🇹Caserta, Italy
A.O. Santa Croce e Carle
🇮🇹Cuneo, Italy
Istituto Ca' Granda-Niguarda
🇮🇹Milano, Italy
Fatebenefratelli S:Giovalli Calibita
🇮🇹Roma, Italy
Osaka University Hospital
🇯🇵Suita, Osaka, Japan
Prince Sultan Cardiac Center
🇸🇦Riyadh, Saudi Arabia
Mediclinic Panorama Hospital
🇿🇦Cape Town, South Africa
Saiseikai Kawaguchi General Hospital
🇯🇵Kawaguchi, Japan
King Fadh Atmnd Forces Hospital
🇸🇦Jeddah, Saudi Arabia
Kagawa University Hospital
🇯🇵Kagawa, Japan
Tokyo Medical and Dental University Hospital
🇯🇵Bunkyō-Ku, Tokyo, Japan
Toyohashi Heart Center
🇯🇵Toyohashi, Japan
S. Anna Hospital
🇮🇹Como, Italy
Ospedale Santa Croce
🇮🇹Fano, Italy
Ospedali Riuniti Leonardi-Riboli
🇮🇹Lavagna, Italy
ASL 2 Avellino
🇮🇹Mercogliano, Italy
Istituto Auxologico Italiano
🇮🇹Milano, Italy
Ospedale Luigi Sacco
🇮🇹Milano, Italy
San Carlo Borromeo
🇮🇹Milano, Italy
Ospedale Sacro Cuore Don Calabria
🇮🇹Negrar, Italy
A.O. di Parma
🇮🇹Parma, Italy
Policlinico S. Matteo
🇮🇹Pavia, Italy
A.O. San Salvatore di Pesaro
🇮🇹Pesaro, Italy
Arcispedale Santa Maria Nuova
🇮🇹Reggio Emilia, Italy
Policlinico A. Gemelli
🇮🇹Roma, Italy
San Filippo Neri Hospital
🇮🇹Roma, Italy
Istituto Clinico Humanitas
🇮🇹Rozzano, Italy
ASL Teramo
🇮🇹Teramo, Italy
A.O. S.Maria della Misericordia
🇮🇹Udine, Italy
Ospedale S. Maria della Misericordia
🇮🇹Urbino, Italy
A.Ospedaliero Universitaria Careggi
🇮🇹Firenze, Italy
Blackpool Victoria Hospital
🇬🇧Blackpool, United Kingdom
Hallandssjukhus Varberg
🇸🇪Varberg, Sweden
Greater Glasgow Health Board
🇬🇧Glasgow, United Kingdom
Central Manchester University Hospital NHS Foundation Trust
🇬🇧Manchester, United Kingdom