Italian ClinicalService Project

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Medtronic Italia
Sponsor:
Information provided by (Responsible Party):
Medtronic Italia
ClinicalTrials.gov Identifier:
NCT01007474
First received: November 3, 2009
Last updated: February 12, 2013
Last verified: February 2013
  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

Resource links provided by NLM:


Further study details as provided by Medtronic Italia:

Primary Outcome Measures:
  • Mortality [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hospitalizations [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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)
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
Detailed Description:

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
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01007474

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

Locations
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         
Sponsors and Collaborators
Medtronic Italia
Investigators
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 August 27, 2014