Device Replacement Clinical Trial
— DECODEOfficial title:
Detect Long-term Complications After ICD Replacement: a Multicenter Italian Registry - DECODE Registry
This study has been designed to prospectively estimate long term complication rates (12-months and 5-years) in patients undergoing Implantable Cardioverter Defibrillator (ICD) replacement, with and without a planned transvenous lead addition for replacement or upgrade to a device capable of additional therapies; the study also evaluates the predictors of complications, the patient's management before and during the replacement procedure in clinical practice and the estimated costs related to the use of health care resources.
Status | Recruiting |
Enrollment | 800 |
Est. completion date | October 2015 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patient implanted with a CardiacResynchronizationTherapy-Defibrillator or single chamber/dual chambers ICD device (any commercially available generator or lead can be included). - Patient with standard indications to ICD generator replacement according to the investigators' clinical assessment. - Patient must be able to attend all required follow-up visits at the study center. Exclusion Criteria: - Patient is less than 18 years of age. - Patient is unwilling or unable to sign an authorization to use and disclose health information or an Informed Consent. - Patient life expectancy is less than 12 months. - Patient is participating in another clinical study that may have an impact on the study endpoints. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Italy | Ospedale "San Donato" | Arezzo | |
Italy | Ospedale Civile S.Agostino-Estense | Baggiovara | Modena |
Italy | Ospedale di Bentivoglio | Bentivoglio | Bologna |
Italy | A.O. "Papa Giovanni XXIII" | Bergamo | BG |
Italy | Azienda Ospedaliera Universitaria , Policlinico Sant'Orsola | Bologna | |
Italy | Ospedale Maggiore | Bologna | |
Italy | Università Cattolica del Sacro Cuore | Campobasso | |
Italy | Ospedale di Venere | Carbonara di Bari | Bari |
Italy | Ospedale SS. Annunziata | Cento | Ferrara |
Italy | Ospedale "Maurizio Bufalini" | Cesena | Forlì |
Italy | Ospedale Cuneo | Cuneo | |
Italy | Ospedale "San Giuseppe" | Empoli | |
Italy | A.O.S.Anna | Ferrara | |
Italy | Ospedale "Morgagni-Pierantoni" | Forlì | |
Italy | Ospedale "Padre Antero Micone" - Sestri Ponente | Genova | |
Italy | Ospedale della Misericordia | Grosseto | |
Italy | Ospedale Maggiore | Lodi | LO |
Italy | Clinica Mediterranea | Napoli | |
Italy | Ospedale Monaldi SUN | Napoli | |
Italy | A.O.U.P. "Paolo Giaccone" | Palermo | PA |
Italy | A.O. Santa Maria della Misericordia | Perugia | |
Italy | Azienda Ospedali Riuniti Marche Nord | Pesaro | |
Italy | Ospedale "Santa Maria delle Croci" | Ravenna | |
Italy | Ospedale Santa Maria Nuova | Reggio Emilia | |
Italy | Ospedale degli Infermi | Rimini | |
Italy | Policlinico Casilino | Roma | |
Italy | Policlinico Universitario "Agostino Gemelli" | Rome | RM |
Italy | A.O. San Giovanni di Dio e Ruggi di Aragona | Salerno | |
Italy | Ospedale Casa Sollievo della Sofferenza | San Giovanni Rotondo | FG |
Italy | Ospedale Santa Maria alle Scotte | Siena | SI |
Italy | Casa di Cura "Villa Verde" | Taranto | TA |
Italy | Ospedale Santa Maria di Cà Foncello | Treviso |
Lead Sponsor | Collaborator |
---|---|
Mauro Biffi |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of complications associated with the ICD replacement / upgrade that occur during a period of 12 months | The primary outcome measure of this study is to estimate, at 12-months follow up, the percentage of subjects undergoing ICD generator replacement, with and without a planned transvenous lead addition for replacement or upgrade to a device capable of additional therapies, experiencing one of the pre-defined complications. | 12 months | No |
Secondary | Baseline patient's characteristics (clinical history and drug therapy) for subjects undergoing ICD replacement/upgrade | This secondary outcome measure of this study is to evaluate baseline patient's characteristics or variables of procedure's management as potential predictors of complications, that will be evaluated at 30 days, at 12 months and 60 months follow up | 60 months | No |
Secondary | - Rate of complications associated with the ICD replacement / upgrade that occur during a very long-term period | This extends to 60 months the results obtained with the primary objective at 12 months | 60 months | No |
Secondary | Long-term costs of ICD/upgrade procedure | This secondary outcome measure of this study is to evaluate resource consumption and associated costs in terms of devices, replacement/upgrade procedures , follow-up, post-replacement/upgrade management of complications and health care resources utilization. | 60 months | No |
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