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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Guidant Corporation
ClinicalTrials.gov Identifier:
NCT00661037
First received: April 7, 2008
Last updated: August 31, 2012
Last verified: August 2012
History of Changes

April 7, 2008
August 31, 2012
March 2008
May 2011   (final data collection date for primary outcome measure)
composite of: 1) severe intra-operative complications at ICD implant 2) events at follow up [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00661037 on ClinicalTrials.gov Archive Site
Severe intra-operative complications or occurring as consequence of defibrillation test; total mortality; survival to ineffective appropriate ICD shocks without resuscitation maneuvers; [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
SAFEty of Two Strategies of ICD Management at Implantation
SAFEty of Two Strategies of ICD Management at Implantation

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

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
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

All patients having the risk of life threatening arrhythmias and indicated for the implant of an implantable cardioverter defibrillator.
  • Ventricular Fibrillation
  • Ventricular Flutter
  • Sudden Cardiac Death
Device: Implantable defibrillator
Implantable defibrillator to reduce ventricular arrhythmias via shock.
Other Name: Not applicable. All devices allowed.
  • 1
    Patients having VF induction with shock termination at implant
    Intervention: Device: Implantable defibrillator
  • 2
    Patients not having VF induction at implant or during follow-up
    Intervention: Device: Implantable defibrillator
Brignole M, Occhetta E, Bongiorni MG, Proclemer A, Favale S, Iacopino S, Calò L, Vado A, Buja G, Mascioli G, Quartieri F, Tritto M, Parravicini U, Castro A, Tomasi C, Villani GQ, D'Acri MG, Klersy C, Gasparini M; SAFE-ICD Study Investigators. Clinical evaluation of defibrillation testing in an unselected population of 2,120 consecutive patients undergoing first implantable cardioverter-defibrillator implant. J Am Coll Cardiol. 2012 Sep 11;60(11):981-7. doi: 10.1016/j.jacc.2012.05.014. Epub 2012 Aug 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2130
September 2011
May 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00661037
2007_SI
Yes
Guidant Corporation
Guidant Corporation
Not Provided
Study Chair: Michele Brignole, MD Ospedali del Tigullio
Guidant Corporation
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP