Clinical trial NCT01007474: One Hospital ClinicalService Project
Official title: One Hospital ClinicalService Project on Patients Implanted With Medtronic Implantable Devices or Treated by Medtronic Therapies
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Arrhythmias, Cardiac
Bradycardia
Syncope
Lead sponsor: Medtronic Italia
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2009-11-04
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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 International Hospitals.

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

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

Primary outcomes:
measure: Mortality
timeFrame: 10 years
Secondary outcomes:
measure: Hospitalizations
timeFrame: 10 years
Other outcomes:
measure: Device interventions
timeFrame: 10 years
Locations:
city: Mutlangen
country: Germany
facility: Stauferklinikum Mutlangen
city: Reykjavík
country: Iceland
facility: Landspitali University Hospital
city: Jaipur
country: India
facility: Eternal Hospital
city: New Delhi
country: India
facility: Fortis Escort Heart Institute
city: Bologna
country: Italy
facility: S.Orsola Malpigli
city: Bolzano
country: Italy
facility: Ospedale Civile di Bolzano
city: Caserta
country: Italy
facility: A.O. S.Sebastiano di Caserta
city: Como
country: Italy
facility: S. Anna Hospital
city: Cuneo
country: Italy
facility: A.O. Santa Croce e Carle
city: Fano
country: Italy
facility: Ospedale Santa Croce
city: Firenze
country: Italy
facility: A.Ospedaliero Universitaria Careggi
city: Lavagna
country: Italy
facility: Ospedali Riuniti Leonardi-Riboli
city: Mercogliano
country: Italy
facility: ASL 2 Avellino
city: Milano
country: Italy
facility: Istituto Auxologico Italiano
city: Milano
country: Italy
facility: Istituto Ca' Granda-Niguarda
city: Milano
country: Italy
facility: Ospedale Luigi Sacco
city: Milano
country: Italy
facility: San Carlo Borromeo
city: Negrar
country: Italy
facility: Ospedale Sacro Cuore Don Calabria
city: Parma
country: Italy
facility: A.O. di Parma
city: Pavia
country: Italy
facility: Policlinico S. Matteo
city: Pesaro
country: Italy
facility: A.O. San Salvatore di Pesaro
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova
city: Roma
country: Italy
facility: Fatebenefratelli S:Giovalli Calibita
city: Roma
country: Italy
facility: Policlinico A. Gemelli
city: Roma
country: Italy
facility: San Filippo Neri Hospital
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: Teramo
country: Italy
facility: ASL Teramo
city: Udine
country: Italy
facility: A.O. S.Maria della Misericordia
city: Urbino
country: Italy
facility: Ospedale S. Maria della Misericordia
city: Suita
country: Japan
facility: Osaka University Hospital
state: Osaka
city: Bunkyō-Ku
country: Japan
facility: Tokyo Medical and Dental University Hospital
state: Tokyo
city: Kagawa
country: Japan
facility: Kagawa University Hospital
city: Kawaguchi
country: Japan
facility: Saiseikai Kawaguchi General Hospital
city: Toyohashi
country: Japan
facility: Toyohashi Heart Center
city: Jeddah
country: Saudi Arabia
facility: King Fadh Atmnd Forces Hospital
city: Riyadh
country: Saudi Arabia
facility: Prince Sultan Cardiac Center
city: Cape Town
country: South Africa
facility: Mediclinic Panorama Hospital
city: Varberg
country: Sweden
facility: Hallandssjukhus Varberg
city: Blackpool
country: United Kingdom
facility: Blackpool Victoria Hospital
city: Glasgow
country: United Kingdom
facility: Greater Glasgow Health Board
city: Manchester
country: United Kingdom
facility: Central Manchester University Hospital NHS Foundation Trust
Study officials:
affiliation: Cardiology Department, Policlinico di Modena, University of Modena and Reggio Emilia
name: Giuseppe Boriani, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.