One Hospital ClinicalService Project

NCT ID: NCT01007474

Last Updated: 2021-02-21

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2030-01-31

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

Conditions

Arrhythmias, Cardiac; Bradycardia; Syncope

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Implantable Cardioverter-Defibrillator (ICD)

Medtronic market-released implantable cardioverter-defibrillator

Intervention Type: DEVICE

Implantable Pacemaker Generator (IPG)

Medtronic market-released implantable pacemaker generator

Intervention Type: DEVICE

Implantable Loop Recorder (ILR)

Medtronic market-released implantable loop recorder

Intervention Type: DEVICE

Cardiac Resynchronization Therapy-Defibrillator (CRT-D)

Medtronic market-released cardiac resynchronization therapy defibrillator

Intervention Type: 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

Intervention Type: DEVICE

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Medtronic Italia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giuseppe Boriani, MD

Role: STUDY_CHAIR

Cardiology Department, Policlinico di Modena, University of Modena and Reggio Emilia

Locations

Stauferklinikum Mutlangen

Mutlangen, , Germany

Landspitali University Hospital

Reykjavik, , 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

S. Anna Hospital

Como, , Italy

A.O. Santa Croce e Carle

Cuneo, , Italy

Ospedale Santa Croce

Fano, , Italy

A.Ospedaliero Universitaria Careggi

Florence, , Italy

Ospedali Riuniti Leonardi-Riboli

Lavagna, , Italy

ASL 2 Avellino

Mercogliano, , Italy

Istituto Auxologico Italiano

Milan, , Italy

Istituto Ca' Granda-Niguarda

Milan, , Italy

Ospedale Luigi Sacco

Milan, , Italy

San Carlo Borromeo

Milan, , 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

Fatebenefratelli S:Giovalli Calibita

Roma, , 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

Osaka University Hospital

Suita, Osaka, Japan

Tokyo Medical and Dental University Hospital

Bunkyō-Ku, Tokyo, Japan

Kagawa University Hospital

Kagawa, , Japan

Saiseikai Kawaguchi General Hospital

Kawaguchi, , Japan

Toyohashi Heart Center

Toyohashi, , Japan

King Fadh Atmnd Forces Hospital

Jeddah, , Saudi Arabia

Prince Sultan Cardiac Center

Riyadh, , Saudi Arabia

Mediclinic Panorama Hospital

Cape Town, , South Africa

Hallandssjukhus Varberg

Varberg, , Sweden

Blackpool Victoria Hospital

Blackpool, , United Kingdom

Greater Glasgow Health Board

Glasgow, , United Kingdom

Central Manchester University Hospital NHS Foundation Trust

Manchester, , United Kingdom

Countries

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

References

Moltrasio M, Iacopino S, Arena G, Pieragnoli P, Molon G, Manfrin M, Verlato R, Ottaviano L, Rovaris G, Catanzariti D, Cipolletta L, Nicolis D, Cattafi G, Tondo C; 1STOP ClinicalService centers. First-line therapy: insights from a real-world analysis of cryoablation in patients with atrial fibrillation. J Cardiovasc Med (Hagerstown). 2021 Aug 1;22(8):618-623. doi: 10.2459/JCM.0000000000001176.

Reference Type: DERIVED

PMID: 34009837 (View on PubMed)

Giannola G, Torcivia R, Airo Farulla R, Cipolla T. Outsourcing the Remote Management of Cardiac Implantable Electronic Devices: Medical Care Quality Improvement Project. JMIR Cardio. 2019 Dec 18;3(2):e9815. doi: 10.2196/cardio.9815.

Reference Type: DERIVED

PMID: 31845898 (View on PubMed)

Ricciardi D, Arena G, Verlato R, Iacopino S, Pieragnoli P, Molon G, Manfrin M, Allocca G, Cattafi G, Sirico G, Rovaris G, Sciarra L, Nicolis D, Tondo C. Sex effect on efficacy of pulmonary vein cryoablation in patients with atrial fibrillation: data from the multicenter real-world 1STOP project. J Interv Card Electrophysiol. 2019 Oct;56(1):9-18. doi: 10.1007/s10840-019-00601-3. Epub 2019 Aug 26.

Reference Type: DERIVED

PMID: 31452001 (View on PubMed)

Perego GB, Iacopino S, Molon G, Arena G, Verlato R, Pieragnoli P, Curnis A, Allocca G, Nicolis D, Sciarra L, Catanzariti D, Senatore G, Rovaris G, Brasca F, Tondo C; ClinicalService 1STOP project i Project Investigators. Cryoablation for paroxysmal and persistent AF in patients with structural heart disease and preserved ejection fraction: Clinical outcomes from 1STOP, a multicenter observational project. J Cardiol. 2019 Jul;74(1):19-26. doi: 10.1016/j.jjcc.2019.02.015. Epub 2019 Apr 1.

Reference Type: DERIVED

PMID: 30948185 (View on PubMed)

Landolina M, Arena G, Iacopino S, Verlato R, Pieragnoli P, Curnis A, Lunati M, Rauhe W, Senatore G, Sciarra L, Molon G, Agricola PMG, Padeletti L, Tondo C. Center experience does not influence long-term outcome and peri-procedural complications after cryoballoon ablation of paroxysmal atrial fibrillation: Data on 860 patients from the real-world multicenter observational project. Int J Cardiol. 2018 Dec 1;272:130-136. doi: 10.1016/j.ijcard.2018.07.051. Epub 2018 Jul 18.

Reference Type: DERIVED

PMID: 30045822 (View on PubMed)

Stabile G, Tondo C, Curnis A, Lunati M, Manfrin M, Molon G, Sciarra L, Mantica M, Iacopino S, Arena G, Landolina M, Arestia A, Verlato R. Efficacy of cryoballoon ablation in patients with paroxysmal atrial fibrillation without time to pulmonary vein isolation assessment. Int J Cardiol. 2018 Dec 1;272:118-122. doi: 10.1016/j.ijcard.2018.07.070. Epub 2018 Jul 20.

Reference Type: DERIVED

PMID: 30037629 (View on PubMed)

Lunati M, Arena G, Iacopino S, Verlato R, Tondo C, Curnis A, Porcellini S, Sciarra L, Molon G, Senatore G, Leoni L, Perego GB, Rauhe W, Pepi P, Landolina M. Is the time between first diagnosis of paroxysmal atrial fibrillation and cryoballoon ablation a predictor of efficacy? J Cardiovasc Med (Hagerstown). 2018 Aug;19(8):446-452. doi: 10.2459/JCM.0000000000000688.

Reference Type: DERIVED

PMID: 29927782 (View on PubMed)

Gasparini M, Kloppe A, Lunati M, Anselme F, Landolina M, Martinez-Ferrer JB, Proclemer A, Morani G, Biffi M, Ricci R, Rordorf R, Mangoni L, Manotta L, Grammatico A, Leyva F, Boriani G. Atrioventricular junction ablation in patients with atrial fibrillation treated with cardiac resynchronization therapy: positive impact on ventricular arrhythmias, implantable cardioverter-defibrillator therapies and hospitalizations. Eur J Heart Fail. 2018 Oct;20(10):1472-1481. doi: 10.1002/ejhf.1117. Epub 2017 Dec 18.

Reference Type: DERIVED

PMID: 29251799 (View on PubMed)

Boriani G, Lip GYH, Ricci RP, Proclemer A, Landolina M, Lunati M, Padeletti L, Zanotto G, Molon G, Biffi M, Rordorf R, Quartieri F, Gasparini M. The increased risk of stroke/transient ischemic attack in women with a cardiac implantable electronic device is not associated with a higher atrial fibrillation burden. Europace. 2017 Nov 1;19(11):1767-1775. doi: 10.1093/europace/euw333.

Reference Type: DERIVED

PMID: 28031277 (View on PubMed)

Padeletti L, Curnis A, Tondo C, Lunati M, Porcellini S, Verlato R, Sciarra L, Senatore G, Catanzariti D, Leoni L, Landolina M, Delise P, Iacopino S, Pieragnoli P, Arena G. Pulmonary Vein Isolation with the Cryoballoon Technique: Feasibility, Procedural Outcomes, and Adoption in the Real World: Data from One Shot Technologies TO Pulmonary Vein Isolation (1STOP) Project. Pacing Clin Electrophysiol. 2017 Jan;40(1):46-56. doi: 10.1111/pace.12975. Epub 2016 Dec 22.

Reference Type: DERIVED

PMID: 27862043 (View on PubMed)

Zoppo F, Facchin D, Molon G, Zanotto G, Catanzariti D, Rossillo A, Baccillieri MS, Menard C, Comisso J, Gentili A, Grammatico A, Bertaglia E, Proclemer A. Improving atrial fibrillation detection in patients with implantable cardiac devices by means of a remote monitoring and management application. Pacing Clin Electrophysiol. 2014 Dec;37(12):1610-8. doi: 10.1111/pace.12474. Epub 2014 Aug 12.

Reference Type: DERIVED

PMID: 25113510 (View on PubMed)

Ricci RP, Pignalberi C, Landolina M, Santini M, Lunati M, Boriani G, Proclemer A, Facchin D, Catanzariti D, Morani G, Gulizia M, Mangoni L, Grammatico A, Gasparini M; ClinicalService cardiological centres. Ventricular rate monitoring as a tool to predict and prevent atrial fibrillation-related inappropriate shocks in heart failure patients treated with cardiac resynchronisation therapy defibrillators. Heart. 2014 Jun;100(11):848-54. doi: 10.1136/heartjnl-2013-305259. Epub 2014 Mar 28.

Reference Type: DERIVED

PMID: 24682569 (View on PubMed)

Verlato R, Facchin D, Catanzariti D, Molon G, Zanotto G, Morani G, Brieda M, Zanon F, Delise P, Leoni L, Comisso J, Campo C. Clinical outcomes in patients with implantable cardioverter defibrillators and Sprint Fidelis leads. Heart. 2013 Jun;99(11):799-804. doi: 10.1136/heartjnl-2012-303259. Epub 2013 Feb 22.

Reference Type: DERIVED

PMID: 23434626 (View on PubMed)

Boriani G, Santini M, Lunati M, Gasparini M, Proclemer A, Landolina M, Padeletti L, Botto GL, Capucci A, Bianchi S, Biffi M, Ricci RP, Vimercati M, Grammatico A, Lip GY; Italian ClinicalService Project. Improving thromboprophylaxis using atrial fibrillation diagnostic capabilities in implantable cardioverter-defibrillators: the multicentre Italian ANGELS of AF Project. Circ Cardiovasc Qual Outcomes. 2012 Mar 1;5(2):182-8. doi: 10.1161/CIRCOUTCOMES.111.964205. Epub 2012 Feb 28.

Reference Type: DERIVED

PMID: 22373906 (View on PubMed)

Landolina M, Gasparini M, Lunati M, Iacopino S, Boriani G, Bonanno C, Vado A, Proclemer A, Capucci A, Zucchiatti C, Valsecchi S, Ricci RP, Santini M; Cardiovascular Centers Participating in the ClinicalService Project. Long-term complications related to biventricular defibrillator implantation: rate of surgical revisions and impact on survival: insights from the Italian Clinical Service Database. Circulation. 2011 Jun 7;123(22):2526-35. doi: 10.1161/CIRCULATIONAHA.110.015024. Epub 2011 May 16.

Reference Type: DERIVED

PMID: 21576653 (View on PubMed)

Santini M, Gasparini M, Landolina M, Lunati M, Proclemer A, Padeletti L, Catanzariti D, Molon G, Botto GL, La Rocca L, Grammatico A, Boriani G; cardiological centers participating in ClinicalService Project. Device-detected atrial tachyarrhythmias predict adverse outcome in real-world patients with implantable biventricular defibrillators. J Am Coll Cardiol. 2011 Jan 11;57(2):167-72. doi: 10.1016/j.jacc.2010.08.624.

Reference Type: DERIVED

PMID: 21211688 (View on PubMed)

Other Identifiers

MDT-OHCS

Identifier Type: -

Identifier Source: org_study_id