Arrhythmias, CardiacOHCSNCT01007474
One Hospital ClinicalService Project
An observational study of Arrhythmias, Cardiac and Bradycardia, run by Medtronic Italia at 41 sites in 9 countries.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arrhythmias, Cardiac, Bradycardia, Syncope
- What is being tested?
- Implantable Cardioverter-Defibrillator (ICD), Implantable Pacemaker Generator (IPG) and Implantable Loop Recorder (ILR)
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 41 sitesin 9 countries
- Study dates
- Jan 2004to Jan 2030
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients wearing a Medtronic market-released device or treated by a Medtronic therapy who have signed a patient data release and informed consent form
Who cannot join
- Patients unwilling or unable to cooperate or give voluntary consent
Trial locations and contacts
41 sites in 9 countries.
41 sites in 9 countries
Italy25 sites
S.Orsola Malpigli
Bologna
Ospedale Civile di Bolzano
Bolzano
A.O. S.Sebastiano di Caserta
Caserta
S. Anna Hospital
Como
A.O. Santa Croce e Carle
Cuneo
Ospedale Santa Croce
Fano
A.Ospedaliero Universitaria Careggi
Florence
Ospedali Riuniti Leonardi-Riboli
Lavagna
ASL 2 Avellino
Mercogliano
Istituto Auxologico Italiano
Milan
Istituto Ca' Granda-Niguarda
Milan
Ospedale Luigi Sacco
Milan
San Carlo Borromeo
Milan
Ospedale Sacro Cuore Don Calabria
Negrar
A.O. di Parma
Parma
Policlinico S. Matteo
Pavia
A.O. San Salvatore di Pesaro
Pesaro
Arcispedale Santa Maria Nuova
Reggio Emilia
Fatebenefratelli S:Giovalli Calibita
Roma
Policlinico A. Gemelli
Roma
San Filippo Neri Hospital
Roma
Istituto Clinico Humanitas
Rozzano
ASL Teramo
Teramo
A.O. S.Maria della Misericordia
Udine
Ospedale S. Maria della Misericordia
Urbino
Japan5 sites
Tokyo Medical and Dental University Hospital
Bunkyō-Ku, Tokyo
Kagawa University Hospital
Kagawa
Saiseikai Kawaguchi General Hospital
Kawaguchi
Osaka University Hospital
Suita, Osaka
Toyohashi Heart Center
Toyohashi
United Kingdom3 sites
Blackpool Victoria Hospital
Blackpool
Greater Glasgow Health Board
Glasgow
Central Manchester University Hospital NHS Foundation Trust
Manchester
Saudi Arabia2 sites
King Fadh Atmnd Forces Hospital
Jeddah
Prince Sultan Cardiac Center
Riyadh
About this study
Official title: One Hospital ClinicalService Project on Patients Implanted With Medtronic Implantable Devices or Treated by Medtronic Therapies
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.
Read the 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
- Being tested
- Implantable Cardioverter-Defibrillator (ICD), Implantable Pacemaker Generator (IPG), Implantable Loop Recorder (ILR), Cardiac Resynchronization Therapy-Defibrillator (CRT-D), Implantable devices working as neurostimulators, stents, spinal/bone devices or other applications
- Medical subject headings
- Arrhythmias, Cardiac, Bradycardia, Syncope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 applicationsDevice
Medtronic market-released implantable devices used as neurostimulators, stents, spinal/bone devices or for other applications
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 10 years
Secondary outcomes (1)
Hospitalizations
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2009 (estimated)
- Study startJan 2004
- Primary completionJan 2028 (estimated)
- Study completionJan 2030 (estimated)
Why it stopped: The One Hospital ClinicalService project involves the provision of services to hospitals, and is not a clinical study. As such, this service offering should not be listed on ClinicalTrials.gov.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Arrhythmias, CardiacStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Italia
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Giuseppe Boriani, MD, Study chair, Cardiology Department, Policlinico di Modena, University of Modena and Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01007474
- Sponsor's protocol ID
- MDT-OHCS
- Acronym
- OHCS
- Status last verified
- Feb 2021
- First submitted
- 3 Nov 2009
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34009837Giannola 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.
PubMed 31845898Ricciardi 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.
PubMed 31452001Perego 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.
PubMed 30948185Landolina 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.
PubMed 30045822Stabile 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.
PubMed 30037629Lunati 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.
PubMed 29927782Gasparini 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.
PubMed 29251799Boriani 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.
PubMed 28031277Padeletti 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.
PubMed 27862043Zoppo 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.
PubMed 25113510Ricci 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.
PubMed 24682569Verlato 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.
PubMed 23434626Boriani 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.
PubMed 22373906Landolina 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.
PubMed 21576653
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Hospital ClinicalService Project on Patients Implanted With Medtronic Implantable Devices or Treated by Medtronic Therapies
- ClinicalTrials.gov ID
- NCT01007474
- Acronym / sponsor ID
- OHCS / MDT-OHCS
- Conditions
- Arrhythmias, Cardiac, Bradycardia, Syncope
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The One Hospital ClinicalService project involves the provision of services to hospitals, and is not a clinical study. As such, this service offering should not be listed on ClinicalTrials.gov.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medtronic ItaliaIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Study start
- Jan 2004
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 4 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients wearing a Medtronic market-released device or treated by a Medtronic therapy who have signed a patient data release and informed consent form
Key exclusion criteria (1 listed)
- Patients unwilling or unable to cooperate or give voluntary consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 applicationsMedtronic market-released implantable devices used as neurostimulators, stents, spinal/bone devices or for other applications | Device | – |
Primary outcome
Mortality
Time frame: 10 years
1 secondary outcome
Hospitalizations
Time frame: 10 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Derived from this study: PubMed 34009837Moltrasio 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.
- Derived from this study: PubMed 31845898Giannola 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.
- Derived from this study: PubMed 31452001Ricciardi 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.
- Derived from this study: PubMed 30948185Perego 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.
- Derived from this study: PubMed 30045822Landolina 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.
- Derived from this study: PubMed 30037629Stabile 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.
- Derived from this study: PubMed 29927782Lunati 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.
- Derived from this study: PubMed 29251799Gasparini 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.
- Derived from this study: PubMed 28031277Boriani 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.
- Derived from this study: PubMed 27862043Padeletti 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.
- Derived from this study: PubMed 25113510Zoppo 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.
- Derived from this study: PubMed 24682569Ricci 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Boriani, MD study chair
Cardiology Department, Policlinico di Modena, University of Modena and Reggio Emilia
41 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arrhythmias, Cardiac and Bradycardia, run by Medtronic Italia at 41 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in Italy, Japan, United Kingdom, India, Saudi Arabia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01007474, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.