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Shockless Implant Evaluation (SIMPLE)

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ClinicalTrials.gov Identifier: NCT00800384
Recruitment Status : Completed
First Posted : December 2, 2008
Results First Posted : December 22, 2015
Last Update Posted : March 30, 2018
Sponsor:
Collaborator:
Guidant Corporation
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Ventricular Fibrillation Ventricular Tachycardia Device: Implantable defibrillator Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Shockless Implant Evaluation
Study Start Date : January 2009
Actual Primary Completion Date : October 2013
Actual Study Completion Date : May 2014


Arm Intervention/treatment
Experimental: 1
ICD implant without defibrillation testing
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.
Active Comparator: 2
ICD implant with defibrillation testing
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00800384


  Show 85 Study Locations
Sponsors and Collaborators
Boston Scientific Corporation
Guidant Corporation
Investigators
Principal Investigator: Jeff Healey, MD Population Health Research Institute Canada
Study Chair: Stuart Connolly, MD Population Health Research Institute Canada