One Hospital ClinicalService Project

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.

Conditions

• Arrhythmias, Cardiac
• Bradycardia
• Syncope

Interventions

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

Sponsors & Collaborators

• Medtronic

  collaborator INDUSTRY

• Medtronic Italia

  lead INDUSTRY

Principal Investigators

• Giuseppe Boriani, MD · Cardiology Department, Policlinico di Modena, University of Modena and Reggio Emilia

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2004-01-31

Primary Completion

2028-01-31

Completion

2030-01-31

Countries

• Germany
• Iceland
• India
• Italy
• Japan
• Saudi Arabia
• South Africa
• Sweden
• United Kingdom

Study Locations