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Italian ClinicalService Project

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ClinicalTrials.gov Identifier: NCT01007474
Recruitment Status : Recruiting
First Posted : November 4, 2009
Last Update Posted : April 11, 2017
Information provided by (Responsible Party):
Medtronic Italia

Brief Summary:
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.

Condition or disease Intervention/treatment
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

Detailed 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

Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Italian ClinicalService Project on Patients Implanted With Medtronic Implantable Devices or Treated by Medtronic Therapies
Study Start Date : January 2004
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2020

Intervention Details:
    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

Primary Outcome Measures :
  1. Mortality [ Time Frame: 10 years ]

Secondary Outcome Measures :
  1. Hospitalizations [ Time Frame: 10 years ]

Other Outcome Measures:
  1. Device interventions [ Time Frame: 10 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01007474

Contact: Andrea Grammatico +39-3356404639 andrea.grammatico@medtronic.com
Contact: Francesco DeSeta +39-335466094 francesco.deseta@medtronic.com

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         
Fatebenefratelli S:Giovalli Calibita Recruiting
Roma, Italy
Principal Investigator: Paolo Azzolini, MD         
Policlinico A. Gemelli Recruiting
Roma, Italy
Principal Investigator: Carlo Ratto, MD         
San Filippo Neri Hospital Recruiting
Roma, Italy
Principal Investigator: Massimo Santini, 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         
Sponsors and Collaborators
Medtronic Italia
Study Chair: Giuseppe Boriani, MD 1 Institute of Cardiology, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, S. Orsola-Malpighi University Hospital, Bologna, Italy; 2 Cardiology Department, Policlinico di Modena, University of Modena and Reggio Emilia

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
First Posted: November 4, 2009    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases
Pathologic Processes