NCT00661037

SAFEty of Two Strategies of ICD Management at Implantation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,120 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• Ventricular Fibrillation
• Ventricular Flutter
• Sudden Cardiac Death

Interventions

Type	Name	Description
DEVICE	Implantable defibrillator	Implantable defibrillator to reduce ventricular arrhythmias via shock.
DEVICE	Implantable defibrillator	Implantable defibrillator to reduce ventricular arrhythmias via shock.

Timeline

• Start date: 2008-03-01
• Primary completion: 2011-05-01
• Completion: 2011-09-01
• First posted: 2008-04-18
• Last updated: 2017-07-21
• Results posted: 2017-06-20

Locations

1 site across 1 country: Italy