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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02076789
Other study ID # 72/2013/O/Oss
Secondary ID
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:

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Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


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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
See also
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Completed NCT02323503 - Assessment of Ventricular Arrhythmia Risk After CRT-D Replacement for Patients With Primary Prevention Indication
Completed NCT00395447 - REPLACE: Implantable Cardiac Pulse Generator Replacement Registry Phase 4