Italian ClinicalService Project
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Purpose
The purpose of the Italian ClinicalService Project is to develop an integrated system composed by a network of Italian hospital departments (for example cardiology departments), a clinical data repository (for example, cardiovascular or neurological 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. These data are prospectively collected and may be mined to perform observational research.
| Condition | Intervention |
|---|---|
|
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 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Italian ClinicalService Project on Patients Implanted With Medtronic Implantable Devices or Treated by Medtronic Therapies |
- Mortality [ Time Frame: 10 years ] [ Designated as safety issue: No ]
- Hospitalizations [ Time Frame: 10 years ] [ Designated as safety issue: No ]
- Device interventions [ Time Frame: 10 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 10000 |
| Study Start Date: | January 2004 |
| Estimated Study Completion Date: | January 2020 |
| Estimated Primary Completion Date: | January 2018 (Final data collection date for primary outcome measure) |
-
Device: Implantable Cardioverter-Defibrillator (ICD)
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. 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 research, education 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
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
The study population consists of patients who received a Medtronic device or were treated by Medtronic therapy (currently available or future market-released devices) at one of the participating study locations in Italy.
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
Contacts and Locations| Contact: Andrea Grammatico | +39-3356404639 | andrea.grammatico@medtronic.com |
| Contact: Francesco DeSeta | +39-335466094 | francesco.deseta@medtronic.com |
| Italy | |
| S.Orsola Malpigli | Recruiting |
| Bologna, Italy | |
| Principal Investigator: Giuseppe Boriani, MD | |
| Ospedale Civile di Bolzano | Recruiting |
| Bolzano, Italy | |
| Principal Investigator: Werner Rahue, MD | |
| A.O. S.Sebastiano di Caserta | Recruiting |
| Caserta, Italy | |
| Principal Investigator: Franco Mascia, MD | |
| S. Anna Hospital | Recruiting |
| Como, Italy | |
| Principal Investigator: Giovanni Luca Botto, MD | |
| A.O. Santa Croce e Carle | Recruiting |
| Cuneo, Italy | |
| Principal Investigator: Antonello Vado, MD | |
| Ospedale Santa Croce | Recruiting |
| Fano, Italy | |
| Principal Investigator: Andrea Pozzolini, MD | |
| A.Ospedaliero Universitaria Careggi | Recruiting |
| Firenze, Italy | |
| Principal Investigator: Luigi Padeletti, MD | |
| Ospedali Riuniti Leonardi-Riboli | Recruiting |
| Lavagna, Italy | |
| Principal Investigator: Michele Brignole, MD | |
| ASL 2 Avellino | Recruiting |
| Mercogliano, Italy | |
| Principal Investigator: Francesco Solimene, MD | |
| Istituto Auxologico Italiano | Recruiting |
| Milano, Italy | |
| Principal Investigator: Giovanni B Perego, MD | |
| Istituto Ca' Granda-Niguarda | Recruiting |
| Milano, Italy | |
| Principal Investigator: Maurizio Lunati, MD | |
| Ospedale Luigi Sacco | Recruiting |
| Milano, Italy | |
| Principal Investigator: Antonio Sagone, MD | |
| San Carlo Borromeo | Recruiting |
| Milano, Italy | |
| Principal Investigator: Marco Bernasconi, MD | |
| Ospedale Sacro Cuore Don Calabria | Recruiting |
| Negrar, Italy | |
| Principal Investigator: Giulio Molon, MD | |
| A.O. di Parma | Recruiting |
| Parma, Italy | |
| Principal Investigator: Angelo Carboni, MD | |
| Policlinico S. Matteo | Recruiting |
| Pavia, Italy | |
| Principal Investigator: Maurizio Landolina, MD | |
| A.O. San Salvatore di Pesaro | Recruiting |
| Pesaro, Italy | |
| Principal Investigator: Attilio Pierantozzi, MD | |
| Arcispedale Santa Maria Nuova | Recruiting |
| Reggio Emilia, Italy | |
| Principal Investigator: Carlo Menozzi, MD | |
| San Filippo Neri Hospital | Recruiting |
| Roma, Italy | |
| Principal Investigator: Massimo Santini, MD | |
| Policlinico A. Gemelli | Recruiting |
| Roma, Italy | |
| Principal Investigator: Carlo Ratto, MD | |
| Fatebenefratelli S:Giovalli Calibita | Recruiting |
| Roma, Italy | |
| Principal Investigator: Paolo Azzolini, MD | |
| Istituto Clinico Humanitas | Recruiting |
| Rozzano, Italy | |
| Principal Investigator: Maurizio Gasparini, MD | |
| ASL Teramo | Recruiting |
| Teramo, Italy | |
| Principal Investigator: Giancarlo Speca, MD | |
| A.O. S.Maria della Misericordia | Recruiting |
| Udine, Italy | |
| Principal Investigator: Alessandro Proclemer, MD | |
| Ospedale S. Maria della Misericordia | Recruiting |
| Urbino, Italy | |
| Principal Investigator: Paolo Busacca, MD | |
| Study Director: | Francesco De Seta | Medtronic Italia |
More Information
No publications provided by Medtronic Italia
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Medtronic Italia |
| ClinicalTrials.gov Identifier: | NCT01007474 History of Changes |
| Other Study ID Numbers: | MDT-ICSP |
| Study First Received: | November 3, 2009 |
| Last Updated: | February 12, 2013 |
| Health Authority: | Italy: Ethics Committee |
Additional relevant MeSH terms:
|
Syncope Arrhythmias, Cardiac Bradycardia Heart Diseases Cardiovascular Diseases Pathologic Processes |
Unconsciousness Consciousness Disorders Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013