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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00661037
Other study ID # 2007_SI
Secondary ID
Status Completed
Phase N/A
First received April 7, 2008
Last updated August 31, 2012
Start date March 2008
Est. completion date September 2011

Study information

Verified date August 2012
Source Guidant Corporation
Contact n/a
Is FDA regulated No
Health authority Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Study type Observational

Clinical Trial Summary

The aim of this prospective observational study is to evaluate the safety, over a follow-up of 2 years, of two strategies, consisting in performing or not performing defibrillation testing(DT) during first implant of implantable cardioverter defibrillator


Description:

The standardized requirements for implantable cardioverter defibrillator (ICD) include defibrillation testing (DT), consisting in induction and termination of ventricular fibrillation (VF). An effective DT has historically been considered part of standard procedures at implant. Nevertheless, implant techniques and technology have evolved during years and nowadays deviations are frequent in clinical practice mainly due to the fact that physicians are seriously concerned about the risk of severe complications related to DT. However, the practice of not performing DT is arbitrary and its safety is yet unproven. This observational study will assess the safety of the two strategies adopted at ICD implant: induction (including patients who undergo DT at implant) and non-induction (including patients who do not undergo DT at implant. No deviation from the centres' current practice in choosing to perform or not perform DT is introduced by this study protocol. The study considers consecutive patients undergoing first implant of ICD


Recruitment information / eligibility

Status Completed
Enrollment 2130
Est. completion date September 2011
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- first implantation of ICD or CRT-D

- Patients undergoing upgrade to ICD or CRT-D from pacemaker

- Patients undergoing upgrade to CRT-D from CRT

- Age 18 or above, or legal age to give written informed consent

Exclusion Criteria:

- Patients who do not give consent to treat their data.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Device:
Implantable defibrillator
Implantable defibrillator to reduce ventricular arrhythmias via shock.
Implantable defibrillator
Implantable defibrillator to reduce ventricular arrhythmias via shock.

Locations

Country Name City State
Italy Ospedali del Tigullio, via Don Bobbio 25 Lavagna

Sponsors (1)

Lead Sponsor Collaborator
Guidant Corporation

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary composite of: 1) severe intra-operative complications at ICD implant 2) events at follow up 2 years Yes
Secondary Severe intra-operative complications or occurring as consequence of defibrillation test; total mortality; survival to ineffective appropriate ICD shocks without resuscitation maneuvers; 2 years Yes
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