DEtect Long-term Complications After icD rEplacement: a Multicenter Italian Registry

Device Replacement Clinical Trial

— DECODE  

Official title:

Detect Long-term Complications After ICD Replacement: a Multicenter Italian Registry - DECODE Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02076789
• Other study ID #: 72/2013/O/Oss
• Status: Recruiting
• Phase: N/A
• First received: February 24, 2014
• Last updated: January 8, 2015
• Start date: March 2013
• Est. completion date: October 2015

Study information

• Verified date: January 2015
• Source: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
• Contact: Mauro Biffi
• Phone: 0039 051 636 3434
• Email: decode.registry[@]libero.it
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Device Replacement
• Device Upgrade
• Long-term Postoperative Complications
• Postoperative Complications
• Resource Consumption and Associated Costs After Device Replacement/Upgrade

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Mauro Biffi

Country where clinical trial is conducted

Italy, 

Outcome

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