SAFEty of Two Strategies of ICD Management at Implantation

Sudden Cardiac Death Clinical Trial

— SAFE-ICD  

Official title:

SAFEty of Two Strategies of ICD Management at Implantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00661037
• Other study ID #: 2007_SI
• 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

Related Conditions & MeSH terms

• Death, Sudden, Cardiac
• Sudden Cardiac Death
• Ventricular Fibrillation
• Ventricular Flutter

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