One Hospital ClinicalService Project

NCT01007474 | Withdrawn

• 1 other identifier: MDT-OHCS
• Study Type: observational
• Target: N/A
• Locations: 9 countries
• Sites: 41

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.

Conditions

Arrhythmias, Cardiac; Bradycardia; Syncope

Outcome Measures

Primary Outcomes (1)

• Mortality

  10 years

Secondary Outcomes (1)

• Hospitalizations

  10 years

Other Outcomes (1)

• Device interventions

  10 years

Interventions

Implantable Cardioverter-Defibrillator (ICD) DEVICE

Medtronic market-released implantable cardioverter-defibrillator

Implantable Pacemaker Generator (IPG) DEVICE

Medtronic market-released implantable pacemaker generator

Implantable Loop Recorder (ILR) DEVICE

Medtronic market-released implantable loop recorder

Cardiac Resynchronization Therapy-Defibrillator (CRT-D) DEVICE

Medtronic market-released cardiac resynchronization therapy defibrillator

Implantable devices working as neurostimulators, stents, spinal/bone devices or other applications DEVICE

Medtronic market-released implantable devices used as neurostimulators, stents, spinal/bone devices or for other applications

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients wearing a Medtronic market-released device or treated by a Medtronic therapy who have signed a patient data release and informed consent form

You may not qualify if:

• Patients unwilling or unable to cooperate or give voluntary consent

Sponsors & Collaborators

• Medtronic Italia: lead
• Medtronic: collaborator

Study Sites (41)

Stauferklinikum Mutlangen

Mutlangen, Germany

Location

Landspitali University Hospital

Reykjavik, Iceland

Location

Eternal Hospital

Jaipur, India

Location

Fortis Escort Heart Institute

New Delhi, India

Location

S.Orsola Malpigli

Bologna, Italy

Location

Ospedale Civile di Bolzano

Bolzano, Italy

Location

A.O. S.Sebastiano di Caserta

Caserta, Italy

Location

S. Anna Hospital

Como, Italy

Location

A.O. Santa Croce e Carle

Cuneo, Italy

Location

Ospedale Santa Croce

Fano, Italy

Location

A.Ospedaliero Universitaria Careggi

Florence, Italy

Location

Ospedali Riuniti Leonardi-Riboli

Lavagna, Italy

Location

ASL 2 Avellino

Mercogliano, Italy

Location

Istituto Auxologico Italiano

Milan, Italy

Location

Istituto Ca' Granda-Niguarda

Milan, Italy

Location

Ospedale Luigi Sacco

Milan, Italy

Location

San Carlo Borromeo

Milan, Italy

Location

Ospedale Sacro Cuore Don Calabria

Negrar, Italy

Location

A.O. di Parma

Parma, Italy

Location

Policlinico S. Matteo

Pavia, Italy

Location

A.O. San Salvatore di Pesaro

Pesaro, Italy

Location

Arcispedale Santa Maria Nuova

Reggio Emilia, Italy

Location

Fatebenefratelli S:Giovalli Calibita

Roma, Italy

Location

Policlinico A. Gemelli

Roma, Italy

Location

San Filippo Neri Hospital

Roma, Italy

Location

Istituto Clinico Humanitas

Rozzano, Italy

Location

ASL Teramo

Teramo, Italy

Location

A.O. S.Maria della Misericordia

Udine, Italy

Location

Ospedale S. Maria della Misericordia

Urbino, Italy

Location

Osaka University Hospital

Suita, Osaka, Japan

Location

Tokyo Medical and Dental University Hospital

Bunkyō-Ku, Tokyo, Japan

Location

Kagawa University Hospital

Kagawa, Japan

Location

Saiseikai Kawaguchi General Hospital

Kawaguchi, Japan

Location

Toyohashi Heart Center

Toyohashi, Japan

Location

King Fadh Atmnd Forces Hospital

Jeddah, Saudi Arabia

Location

Prince Sultan Cardiac Center

Riyadh, Saudi Arabia

Location

Mediclinic Panorama Hospital

Cape Town, South Africa

Location

Hallandssjukhus Varberg

Varberg, Sweden

Location

Blackpool Victoria Hospital

Blackpool, United Kingdom

Location

Greater Glasgow Health Board

Glasgow, United Kingdom

Location

Central Manchester University Hospital NHS Foundation Trust

Manchester, United Kingdom

Location

Related Publications (16)

• 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.

  PMID: 34009837 DERIVED

• 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.

  PMID: 31845898 DERIVED

• 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.

  PMID: 31452001 DERIVED

• 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.

  PMID: 30948185 DERIVED

• 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.

  PMID: 30045822 DERIVED

• 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.

  PMID: 30037629 DERIVED

• 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.

  PMID: 29927782 DERIVED

• 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.

  PMID: 29251799 DERIVED

• 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.

  PMID: 28031277 DERIVED

• 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.

  PMID: 27862043 DERIVED

• 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.

  PMID: 25113510 DERIVED

• 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.

  PMID: 24682569 DERIVED

• 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.

  PMID: 23434626 DERIVED

• 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.

  PMID: 22373906 DERIVED

• 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.

  PMID: 21576653 DERIVED

• 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.

  PMID: 21211688 DERIVED

MeSH Terms

Conditions

Arrhythmias, Cardiac; Bradycardia; Syncope

Interventions

Defibrillators, Implantable; Stents

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Defibrillators; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Electrodes, Implanted; Prostheses and Implants

Study Officials

• Giuseppe Boriani, MD

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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2009
• First Posted: November 4, 2009
• Study Start: January 1, 2004
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2030
• Last Updated: February 21, 2021

Record last verified: 2021-02

Locations

IN (2); DE (1); SE (1); JP (5); IT (25); GB (3); ZA (1); SA (2); IC (1)