Device ReplacementDECODENCT02076789
DEtect Long-term Complications After icD rEplacement: a Multicenter Italian Registry
An observational study of Device Replacement and Device Upgrade, run by Mauro Biffi at 32 sites in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Device Replacement, Device Upgrade, Long-term Postoperative Complications
- How many people
- 800 participants
- Where
- 32 sitesItaly
- Study dates
- Mar 2013to Oct 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients undergoing ICD generator replacement, with and without a planned transvenous lead addition for replacement or upgrade to a device capable of additional therapies (consecutive patients)
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
Italy32 sites, 32 recruiting
- Recruiting
Ospedale "San Donato"
Arezzo, 52100
- Recruiting
Ospedale Civile S.Agostino-Estense
Baggiovara, Modena
Mauro Zennaro
- Recruiting
Ospedale di Bentivoglio
Bentivoglio, Bologna, 40010
- Recruiting
A.O. "Papa Giovanni XXIII"
Bergamo, BG, 24123
Paolo De Filippo
- Recruiting
Ospedale Maggiore
Bologna, 40133
Valeria Carinci
Francesco Pergolini
- Recruiting
Azienda Ospedaliera Universitaria , Policlinico Sant'Orsola
Bologna, 40138
Mauro Biffi
- Recruiting
Università Cattolica del Sacro Cuore
Campobasso
Quintino Parisi
Matteo Santamaria
- Recruiting
Ospedale di Venere
Carbonara di Bari, Bari, 70131
- Recruiting
Ospedale SS. Annunziata
Cento, Ferrara, 44011
- Recruiting
Ospedale "Maurizio Bufalini"
Cesena, Forlì, 47521
- Recruiting
Ospedale Cuneo
Cuneo, 12100
Endrj Menardi
- Recruiting
Ospedale "San Giuseppe"
Empoli, 50053
Attilio Del Rosso
- Recruiting
A.O.S.Anna
Ferrara, 44124
Tiziano Toselli
Matteo Bertini
- Recruiting
Ospedale "Morgagni-Pierantoni"
Forlì, 47121
- Recruiting
Ospedale "Padre Antero Micone" - Sestri Ponente
Genova, 16153
Massimo Zoni Berisso
- Recruiting
Ospedale della Misericordia
Grosseto, 58100
Gennaro Miracapillo
- Recruiting
Ospedale Maggiore
Lodi, LO, 26900
Fabio Lissoni
- Recruiting
Clinica Mediterranea
Naples, 80122
Giuseppe Stabile
Assunta Iuliano
- Recruiting
Ospedale Monaldi SUN
Naples
Ernesto Ammendola
Giuseppe Del Giorno
- Recruiting
A.O.U.P. "Paolo Giaccone"
Palermo, PA, 90010
Gianfranco Ciaramitaro
- Recruiting
A.O. Santa Maria della Misericordia
Perugia
Gianluca Zingarini
- Recruiting
Azienda Ospedali Riuniti Marche Nord
Pesaro, 61121
Attilio Pierantozzi
- Recruiting
Ospedale "Santa Maria delle Croci"
Ravenna, 48121
- Recruiting
Ospedale Santa Maria Nuova
Reggio Emilia
Matteo Iori
- Recruiting
Ospedale degli Infermi
Rimini, 47900
- Recruiting
Policlinico Casilino
Roma, 00169
Leonardo Calò
Marco Rebecchi
- Recruiting
Policlinico Universitario "Agostino Gemelli"
Rome, RM, 00100
Maria Lucia Narducci
- Recruiting
A.O. San Giovanni di Dio e Ruggi di Aragona
Salerno, 84131
Andrea Campana
- Recruiting
Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, FG, 71013
- Recruiting
Ospedale Santa Maria alle Scotte
Siena, SI, 53100
Valerio Zacà
- Recruiting
Casa di Cura "Villa Verde"
Taranto, TA, 74121
Mariano Rillo
- Recruiting
Ospedale Santa Maria di Cà Foncello
Treviso
Vittorio Calzolari
About this study
Official 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.
Read the detailed description
Based on positive outcomes from numerous randomized, controlled trials, the implantable defibrillators have been included in the current European Society of Cardiology (ESC) and American College of Cardiology / American Heart Associations (ACC/AHA) guidelines as a standard of care in selected patients, and thus ICD use is currently increasing worldwide.
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
- Device Replacement, Device Upgrade, Long-term Postoperative Complications, Resource Consumption and Associated Costs After Device Replacement/Upgrade
- Keywords
- Device Replacement, Device Upgrade, Long-term Postoperative Complications, Resource consumption and associated costs after device replacement/upgrade
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ICD generator replacement | Patients with standard indications to ICD generator replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (3)
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
Measured: 60 months
- 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
Measured: 60 months
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.
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Study startMar 2013
- Primary completionOct 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Device ReplacementStudies 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
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mauro Biffi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mauro Biffi, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02076789
- Sponsor's protocol ID
- 72/2013/O/Oss
- Acronym
- DECODE
- Status last verified
- Jan 2015
- First submitted
- 24 Feb 2014
- Last updated
- 9 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33249200Biffi 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.
PubMed 31209482Zanon 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.
PubMed 27094359Diemberger 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.
PubMed 26282191
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detect Long-term Complications After ICD Replacement: a Multicenter Italian Registry - DECODE Registry
- ClinicalTrials.gov ID
- NCT02076789
- Acronym / sponsor ID
- DECODE / 72/2013/O/Oss
- Conditions
- Device Replacement, Device Upgrade, Long-term Postoperative Complications, Resource Consumption and Associated Costs After Device Replacement/Upgrade
- Keywords
- Device Replacement, Device Upgrade, Long-term Postoperative Complications, Resource consumption and associated costs after device replacement/upgrade
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Mauro BiffiUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 4 Mar 2014 (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.
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.
Detailed description
Based on positive outcomes from numerous randomized, controlled trials, the implantable defibrillators have been included in the current European Society of Cardiology (ESC) and American College of Cardiology / American Heart Associations (ACC/AHA) guidelines as a standard of care in selected patients, and thus ICD use is currently increasing worldwide.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICD generator replacement | – | –Patients with standard indications to ICD generator replacement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing ICD generator replacement, with and without a planned transvenous lead addition for replacement or upgrade to a device capable of additional therapies (consecutive patients)
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of complications associated with the ICD replacement / upgrade that occur during a period of 12 months
Time frame: 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.
3 secondary outcomes
Baseline patient's characteristics (clinical history and drug therapy) for subjects undergoing ICD replacement/upgrade
Time frame: 60 months
- Rate of complications associated with the ICD replacement / upgrade that occur during a very long-term period
Time frame: 60 months
Long-term costs of ICD/upgrade procedure
Time frame: 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2015.
- Derived from this study: PubMed 33249200Zoni-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.
- Derived from this study: PubMed 31209482Biffi 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.
- Derived from this study: PubMed 27094359Zanon 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.
- Derived from this study: PubMed 26282191Diemberger 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.
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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.
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Device Replacement and Device Upgrade, run by Mauro Biffi at 32 sites in Italy.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 9 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mauro Biffi (0039 051 636 3434, decode.registry@libero.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of complications associated with the ICD replacement / upgrade that occur during a period of 12 months (time frame: 12 months). 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 NCT02076789, which also lists 4 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 9 Jan 2015.