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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

Tracking Information
First Submitted Date  ICMJE November 27, 2008
First Posted Date  ICMJE December 2, 2008
Results First Submitted Date  ICMJE October 13, 2015
Results First Posted Date  ICMJE December 22, 2015
Last Update Posted Date March 30, 2018
Study Start Date  ICMJE January 2009
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 1, 2008)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2015)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2008)
Complication rate [ Time Frame: 30 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Shockless Implant Evaluation
Official Title  ICMJE Shockless Implant Evaluation
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Ventricular Fibrillation
  • Ventricular Tachycardia
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: 1
    ICD implant without defibrillation testing
    Intervention: Device: Implantable defibrillator
  • Active Comparator: 2
    ICD implant with defibrillation testing
    Intervention: Device: Implantable defibrillator
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 1, 2008)
2500
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Canada,   Czechia,   Finland,   France,   Germany,   Hong Kong,   Hungary,   Israel,   Malaysia,   Netherlands,   Norway,   Poland,   Spain,   Sweden,   Thailand,   United Kingdom
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT00800384
Other Study ID Numbers  ICMJE 11-2007
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boston Scientific Corporation
Study Sponsor  ICMJE Boston Scientific Corporation
Collaborators  ICMJE Guidant Corporation
Investigators  ICMJE
Principal Investigator: Jeff Healey, MD Population Health Research Institute Canada
Study Chair: Stuart Connolly, MD Population Health Research Institute Canada
PRS Account Boston Scientific Corporation
Verification Date March 2014

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