SAFEty of Two Strategies of ICD Management at Implantation (SAFE-ICD)

Boston Scientific logo

Boston Scientific

Status

Completed

Conditions

Ventricular Flutter
Ventricular Fibrillation
Sudden Cardiac Death

Treatments

Device: Implantable defibrillator

Study type

Observational

Funder types

Industry

Identifiers

NCT00661037
2007_SI

Details and patient eligibility

About

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

Full 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

Enrollment

2,120 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

2,120 participants in 2 patient groups

1
Description:
Patients having VF induction with shock termination at implant
Treatment:
Device: Implantable defibrillator
2
Description:
Patients not having VF induction at implant or during follow-up
Treatment:
Device: Implantable defibrillator

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems