DEtect Long-term Complications After icD rEplacement: a Multicenter Italian Registry
NCT ID: NCT02076789
Last Updated: 2015-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
800 participants
OBSERVATIONAL
2013-03-31
2015-10-31
Brief Summary
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Detailed Description
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In the years after initial implantation, device replacement may become necessary for battery depletion or for upgrades to more complex multi-lead ICDs. The increase in generator or lead advisories and recalls contributes further to those patients considered for replacement.
The determination of procedural adverse events is complex, and requires monitoring of both short-term complications and long-term patient outcome.
Previous retrospective series have examined complications with ICD replacements. Moreover, the more recent REPLACE registry prospectively collected 6-month complication rates in patients undergoing pacemaker or ICD generator replacement at 72 private practice and academic sites in United States. This study examined a broad range of major and minor complications and found that ICD replacements were associated with a notable complication risk, particularly when a transvenous lead addition or revision was required.
Previous retrospective series have examined complications with ICD implantation in the Italian clinical practice, showing frequent interventions for system revision and demonstrating an association between adverse events and the complexity of the implanted device (i.e. Cardiac Resynchronization Therapy CRT-D versus single- or dual-chamber ICD). Moreover, it was shown that device replacement procedures are associated with significantly higher risk of infections.
Nonetheless, detailed data on the complications of ICD replacement in the current Italian clinical practice are unavailable.
This information would be particularly important because ICD replacement-related events may be associated not only with a worse clinical outcome, but also with incremental costs to the healthcare system.
The analysis of adverse events would permit to study new preventative strategies with significant clinical as well as financial benefits. Moreover, the quantification of the complication rate after ICD replacement would permit to estimate the actual long-term cost of ICD therapy, and to assess the impact of ICD longevity on the cost-effectiveness of the therapy.
This study has been designed to prospectively estimate long term complication rates (at 12-months and 5-years) in patients undergoing ICD generator replacement. The study also evaluates predictors of complications, patient's management before and during the replacement procedure in clinical practice and the estimated costs related to the use of health care resources.
All consecutive patients with standard indications to ICD generator replacement will be enrolled In this study. The decision to perform the generator replacement or to upgrade an existing device will be made according to the investigators' clinical assessment of their patient. The study do not mandate specific surgical or implantation techniques such as venous access, use of temporary pacemakers, or surgical site choices. Any commercially available generator or lead can be included.
Patients will be followed for a 60-month period with periodical in-hospital visits or remote ICD interrogations via remote patient monitoring (RPM) systems, according to the standard hospital practice and the physician's discretion.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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ICD generator replacement
Patients with standard indications to ICD generator replacement
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Mauro Biffi
OTHER
Responsible Party
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Mauro Biffi
Dirigente Medico di Cardiologia
Locations
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Ospedale di Venere
Carbonara di Bari, Bari, Italy
A.O. "Papa Giovanni XXIII"
Bergamo, BG, Italy
Ospedale di Bentivoglio
Bentivoglio, Bologna, Italy
Ospedale SS. Annunziata
Cento, Ferrara, Italy
Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, FG, Italy
Ospedale "Maurizio Bufalini"
Cesena, Forlì, Italy
Ospedale Maggiore
Lodi, LO, Italy
Ospedale Civile S.Agostino-Estense
Baggiovara, Modena, Italy
A.O.U.P. "Paolo Giaccone"
Palermo, PA, Italy
Policlinico Universitario "Agostino Gemelli"
Rome, RM, Italy
Ospedale Santa Maria alle Scotte
Siena, SI, Italy
Casa di Cura "Villa Verde"
Taranto, TA, Italy
Ospedale "San Donato"
Arezzo, , Italy
Ospedale Maggiore
Bologna, , Italy
Azienda Ospedaliera Universitaria , Policlinico Sant'Orsola
Bologna, , Italy
Università Cattolica del Sacro Cuore
Campobasso, , 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
Clinica Mediterranea
Napoli, , Italy
Ospedale Monaldi SUN
Napoli, , 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
A.O. San Giovanni di Dio e Ruggi di Aragona
Salerno, , Italy
Ospedale Santa Maria di Cà Foncello
Treviso, , Italy
Countries
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Central Contacts
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References
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Zoni-Berisso M, Martignani C, Ammendola E, Narducci ML, Caruso D, Miracapillo G, Notarstefano P, Carinci V, Pierantozzi A, Ciaramitaro G, Calo L, Zennaro M, Infusino T, Ferretti C, Sassone B, Licciardello G, Setti S, Terzaghi C, Malacrida M, Biffi M. Mortality after cardioverter-defibrillator replacement: Results of the DECODE survival score index. Heart Rhythm. 2021 Mar;18(3):411-418. doi: 10.1016/j.hrthm.2020.11.024. Epub 2020 Nov 27.
Biffi M, Ammendola E, Menardi E, Parisi Q, Narducci ML, De Filippo P, Manzo M, Stabile G, Potenza DR, Zanon F, Quartieri F, Rillo M, Saporito D, Zaca V, Berisso MZ, Bertini M, Tumietto F, Malacrida M, Diemberger I. Real-life outcome of implantable cardioverter-defibrillator and cardiac resynchronization defibrillator replacement/upgrade in a contemporary population: observations from the multicentre DECODE registry. Europace. 2019 Oct 1;21(10):1527-1536. doi: 10.1093/europace/euz166.
Zanon F, Martignani C, Ammendola E, Menardi E, Narducci ML, DE Filippo P, Santamaria M, Campana A, Stabile G, Potenza DR, Pastore G, Iori M, LA Rosa C, Biffi M. Device Longevity in a Contemporary Cohort of ICD/CRT-D Patients Undergoing Device Replacement. J Cardiovasc Electrophysiol. 2016 Jul;27(7):840-5. doi: 10.1111/jce.12990. Epub 2016 Jun 17.
Diemberger I, Parisi Q, De Filippo P, Narducci ML, Zanon F, Potenza DR, Ciaramitaro G, Malacrida M, Boriani G, Biffi M. Detect Long-term Complications After ICD Replacement (DECODE): Rationale and Study Design of a Multicenter Italian Registry. Clin Cardiol. 2015 Oct;38(10):577-84. doi: 10.1002/clc.22440. Epub 2015 Aug 18.
Other Identifiers
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72/2013/O/Oss
Identifier Type: -
Identifier Source: org_study_id
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