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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2015 by Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi.
Recruitment status was:  Recruiting
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: January 8, 2015
Last verified: January 2015
  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

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 ]
    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 ]
    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 ]
    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 ]
    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 Study Completion Date: October 2015
Estimated Primary Completion Date: October 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   (Adult, Senior)
Sexes Eligible for Study:   All
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

Locations
Italy
Ospedale di Venere
Carbonara di Bari, Bari, Italy, 70131
A.O. "Papa Giovanni XXIII"
Bergamo, BG, Italy, 24123
Ospedale di Bentivoglio
Bentivoglio, Bologna, Italy, 40010
Ospedale SS. Annunziata
Cento, Ferrara, Italy, 44011
Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, FG, Italy, 71013
Ospedale "Maurizio Bufalini"
Cesena, Forlì, Italy, 47521
Ospedale Maggiore
Lodi, LO, Italy, 26900
Ospedale Civile S.Agostino-Estense
Baggiovara, Modena, Italy
A.O.U.P. "Paolo Giaccone"
Palermo, PA, Italy, 90010
Policlinico Universitario "Agostino Gemelli"
Rome, RM, Italy, 00100
Ospedale Santa Maria alle Scotte
Siena, SI, Italy, 53100
Casa di Cura "Villa Verde"
Taranto, TA, Italy, 74121
Ospedale "San Donato"
Arezzo, Italy, 52100
Ospedale Maggiore
Bologna, Italy, 40133
Azienda Ospedaliera Universitaria , Policlinico Sant'Orsola
Bologna, Italy, 40138
Università Cattolica del Sacro Cuore
Campobasso, Italy
Ospedale Cuneo
Cuneo, Italy, 12100
Ospedale "San Giuseppe"
Empoli, Italy, 50053
A.O.S.Anna
Ferrara, Italy, 44124
Ospedale "Morgagni-Pierantoni"
Forlì, Italy, 47121
Ospedale "Padre Antero Micone" - Sestri Ponente
Genova, Italy, 16153
Ospedale della Misericordia
Grosseto, Italy, 58100
Clinica Mediterranea
Napoli, Italy, 80122
Ospedale Monaldi SUN
Napoli, Italy
A.O. Santa Maria della Misericordia
Perugia, Italy
Azienda Ospedali Riuniti Marche Nord
Pesaro, Italy, 61121
Ospedale "Santa Maria delle Croci"
Ravenna, Italy, 48121
Ospedale Santa Maria Nuova
Reggio Emilia, Italy
Ospedale degli Infermi
Rimini, Italy, 47900
Policlinico Casilino
Roma, Italy, 00169
A.O. San Giovanni di Dio e Ruggi di Aragona
Salerno, Italy, 84131
Ospedale Santa Maria di Cà Foncello
Treviso, Italy
Sponsors and Collaborators
Mauro Biffi
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: January 8, 2015

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 January 19, 2017