Shockless Implant Evaluation (SIMPLE)

This study has been completed.
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Guidant Corporation
ClinicalTrials.gov Identifier:
NCT00800384
First received: November 27, 2008
Last updated: March 10, 2015
Last verified: March 2014

November 27, 2008
March 10, 2015
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 ICD or arrhythmic death [ Time Frame: Mean follow-up of 3 years ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00800384 on ClinicalTrials.gov Archive Site
Complication rate [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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 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
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 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
Healey JS, Hohnloser SH, Glikson M, Neuzner J, Mabo P, Vinolas X, Kautzner J, O'Hara G, VanErven L, Gadler F, Pogue J, Appl U, Gilkerson J, Pochet T, Stein KM, Merkely B, Chrolavicius S, Meeks B, Foldesi C, Thibault B, Connolly SJ; Shockless IMPLant Evaluation [SIMPLE] investigators. Cardioverter defibrillator implantation without induction of ventricular fibrillation: a single-blind, non-inferiority, randomised controlled trial (SIMPLE). Lancet. 2015 Feb 28;385(9970):785-91. doi: 10.1016/S0140-6736(14)61903-6. Epub 2015 Feb 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2500
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Canada,   Czech Republic,   Finland,   France,   Germany,   Hong Kong,   Hungary,   Israel,   Malaysia,   Netherlands,   Norway,   Poland,   Spain,   Sweden,   Thailand,   United Kingdom
 
NCT00800384
11-2007
Yes
Guidant Corporation
Guidant Corporation
Boston Scientific Corporation
Principal Investigator: Jeff Healey, MD Population Health Research Institute Canada
Study Chair: Stuart Connolly, MD Population Health Research Institute Canada
Guidant Corporation
March 2014

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