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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Sponsor:
Information provided by (Responsible Party):
Mauro Biffi, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier:
NCT02076789
First received: February 24, 2014
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Detect Long-term Complications After ICD Replacement: a Multicenter Italian Registry - DECODE Registry

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:

Primary Outcome Measures:
  • Rate of complications associated with the ICD replacement / upgrade that occur during a period of 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Baseline patient's characteristics (clinical history and drug therapy) for subjects undergoing ICD replacement/upgrade [ Time Frame: 60 months ] [ Designated as safety issue: No ]
    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

  • - Rate of complications associated with the ICD replacement / upgrade that occur during a very long-term period [ Time Frame: 60 months ] [ Designated as safety issue: No ]
    This extends to 60 months the results obtained with the primary objective at 12 months

  • Long-term costs of ICD/upgrade procedure [ Time Frame: 60 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 800
Study Start Date: March 2013
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
ICD generator replacement
Patients with standard indications to ICD generator replacement

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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)

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02076789

Contacts
Contact: Mauro Biffi 0039 051 636 3434 decode.registry@libero.it

Locations
Italy
Ospedale di Venere Recruiting
Carbonara di Bari, Bari, Italy, 70131
A.O. "Papa Giovanni XXIII" Recruiting
Bergamo, BG, Italy, 24123
Principal Investigator: Paolo De Filippo         
Ospedale di Bentivoglio Recruiting
Bentivoglio, Bologna, Italy, 40010
Ospedale SS. Annunziata Recruiting
Cento, Ferrara, Italy, 44011
Ospedale Casa Sollievo della Sofferenza Recruiting
San Giovanni Rotondo, FG, Italy, 71013
Ospedale "Maurizio Bufalini" Recruiting
Cesena, Forlì, Italy, 47521
Ospedale Maggiore Recruiting
Lodi, LO, Italy, 26900
Principal Investigator: Fabio Lissoni         
A.O.U.P. "Paolo Giaccone" Recruiting
Palermo, PA, Italy, 90010
Principal Investigator: Gianfranco Ciaramitaro         
Policlinico Universitario "Agostino Gemelli" Recruiting
Rome, RM, Italy, 00100
Principal Investigator: Maria Lucia Narducci         
Ospedale Santa Maria alle Scotte Recruiting
Siena, SI, Italy, 53100
Principal Investigator: Valerio Zacà         
Casa di Cura "Villa Verde" Recruiting
Taranto, TA, Italy, 74121
Principal Investigator: Mariano Rillo         
Ospedale "San Donato" Recruiting
Arezzo, Italy, 52100
Azienda Ospedaliera Universitaria , Policlinico Sant'Orsola Recruiting
Bologna, Italy, 40138
Principal Investigator: Mauro Biffi         
Ospedale Maggiore Recruiting
Bologna, Italy, 40133
Principal Investigator: Valeria Carinci         
Principal Investigator: Francesco Pergolini         
Ospedale Cuneo Recruiting
Cuneo, Italy, 12100
Principal Investigator: Endrj Menardi         
Ospedale "San Giuseppe" Recruiting
Empoli, Italy, 50053
Principal Investigator: Attilio Del Rosso         
A.O.S.Anna Recruiting
Ferrara, Italy, 44124
Principal Investigator: Tiziano Toselli         
Principal Investigator: Matteo Bertini         
Ospedale "Morgagni-Pierantoni" Recruiting
Forlì, Italy, 47121
Ospedale della Misericordia Recruiting
Grosseto, Italy, 58100
Principal Investigator: Gennaro Miracapillo         
Clinica Mediterranea Recruiting
Napoli, Italy, 80122
Principal Investigator: Giuseppe Stabile         
Principal Investigator: Assunta Iuliano         
A.O. Santa Maria della Misericordia Recruiting
Perugia, Italy
Principal Investigator: Gianluca Zingarini         
Azienda Ospedali Riuniti Marche Nord Recruiting
Pesaro, Italy, 61121
Principal Investigator: Attilio Pierantozzi         
Ospedale "Santa Maria delle Croci" Recruiting
Ravenna, Italy, 48121
Ospedale degli Infermi Recruiting
Rimini, Italy, 47900
Policlinico Casilino Recruiting
Roma, Italy, 00169
Principal Investigator: Leonardo Calò         
Sub-Investigator: Marco Rebecchi         
A.O. San Giovanni di Dio e Ruggi di Aragona Recruiting
Salerno, Italy, 84131
Principal Investigator: Andrea Campana         
Sponsors and Collaborators
Mauro Biffi
  More Information

No publications provided

Responsible Party: Mauro Biffi, Dirigente Medico di Cardiologia, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier: NCT02076789     History of Changes
Other Study ID Numbers: 72/2013/O/Oss
Study First Received: February 24, 2014
Last Updated: July 17, 2014
Health Authority: Italy: Ministry of Health

Keywords provided by Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:
Device Replacement
Device Upgrade
Long-term Postoperative Complications
Resource consumption and associated costs after device replacement/upgrade

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014