Shockless Implant Evaluation (SIMPLE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00800384
Recruitment Status : Completed
First Posted : December 2, 2008
Results First Posted : December 22, 2015
Last Update Posted : March 30, 2018
Guidant Corporation
Information provided by (Responsible Party):
Boston Scientific Corporation

November 27, 2008
December 2, 2008
October 13, 2015
December 22, 2015
March 30, 2018
January 2009
October 2013   (Final data collection date for primary outcome measure)
First Occurrence of the Composite of Failed First Appropriate Clinical Shock From the Implantable Cardioverter Defibrillator (ICD) or Arrhythmic Death [ Time Frame: Mean follow-up of 3.1 years ]
The number of patients having experienced either an appropriate inefficient shock and/or arrhythmic death during the follow-up time frame of 3.1 years is compared between both groups.
First occurrence of the composite of failed first appropriate clinical shock from the ICD or arrhythmic death [ Time Frame: Mean follow-up of 2 years ]
Complete list of historical versions of study NCT00800384 on Archive Site
Perioperative Complication Rate [ Time Frame: 30 days ]
A predefined set of expected complications attributed to defibrillation testing during implant procedure was analyzed in both groups.
Complication rate [ Time Frame: 30 days ]
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Shockless Implant Evaluation
Shockless Implant Evaluation

This trial will assess the safety of defibrillator testing and the influence of defibrillation testing on the efficacy of clinical shocks.

The trial will test the hypothesis that implantable cardioverter defibrillator (ICD) implantation without defibrillation testing (DT) is non-inferior to implantation with testing against the composite endpoint of ineffective first appropriate clinical shock or arrhythmic death.

It will also test the hypothesis, that defibrillation testing increases the peri-operative (30 days) complication rate of ICD implantation.

Not Provided
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
  • Ventricular Fibrillation
  • Ventricular Tachycardia
Device: Implantable defibrillator
Implantable defibrillator to detect and terminate ventricular arrhythmias
Other Names:
  • Study is not device specific.
  • Any market released ICD including cardiac resynchromization therapy (CRT)-Ds can be included.
  • Experimental: 1
    ICD implant without defibrillation testing
    Intervention: Device: Implantable defibrillator
  • Active Comparator: 2
    ICD implant with defibrillation testing
    Intervention: Device: Implantable defibrillator

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
May 2014
October 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age ≥ 18 years
  • Patients undergoing initial implant of an ICD or CRT-D device (can be upgrade from a pacemaker)

Exclusion Criteria:

  • Patients, who in the opinion of their treating physicians are ineligible for either strategy (DT or no DT)
  • Patients on active transplant list
  • Patients unwilling to provide informed consent
  • Patients not available for follow-up
  • Pregnancy or women of child bearing potential not following an effective method of contraception
  • Anticipated right sided implantation of the ICD generator
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Canada,   Czechia,   Finland,   France,   Germany,   Hong Kong,   Hungary,   Israel,   Malaysia,   Netherlands,   Norway,   Poland,   Spain,   Sweden,   Thailand,   United Kingdom
Czech Republic
Not Provided
Not Provided
Boston Scientific Corporation
Boston Scientific Corporation
Guidant Corporation
Principal Investigator: Jeff Healey, MD Population Health Research Institute Canada
Study Chair: Stuart Connolly, MD Population Health Research Institute Canada
Boston Scientific Corporation
March 2014

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