Shockless Implant Evaluation (SIMPLE)

This study has been completed.
Sponsor:
Collaborator:
Guidant Corporation
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00800384
First received: November 27, 2008
Last updated: January 5, 2016
Last verified: March 2014
Results First Received: October 13, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Supportive Care
Conditions: Ventricular Fibrillation
Ventricular Tachycardia
Intervention: Device: Implantable defibrillator

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First patient was recruited 13 January 2014, last patient was recruited 4 April 2011. All patients were part of the general ICD population at participating sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
ICD Implant Without Defibrillation Testing Patients in this arm were implanted with their ICD without having the defibrillation test performed at implant. No VF induction was performed.
ICD Implant With Defibrillation Testing Patients in this arm were implanted with their ICD and VF induction was performed followed by shock delivery to test shock efficacy at implant.

Participant Flow:   Overall Study
    ICD Implant Without Defibrillation Testing     ICD Implant With Defibrillation Testing  
STARTED     1247     1253  
COMPLETED     1206     1210  
NOT COMPLETED     41     43  
Withdrawal by Subject                 24                 17  
Lost to Follow-up                 17                 26  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
ICD Implant Without Defibrillation Testing Patients in this arm were implanted with their ICD without having the defibrillation test performed at implant. No VF induction was performed.
ICD Implant With Defibrillation Testing Patients in this arm were implanted with their ICD and VF induction was performed followed by shock delivery to test shock efficacy at implant.
Total Total of all reporting groups

Baseline Measures
    ICD Implant Without Defibrillation Testing     ICD Implant With Defibrillation Testing     Total  
Number of Participants  
[units: participants]
  1247     1253     2500  
Age  
[units: years]
Mean (Standard Deviation)
  62.58  (11.51)     62.98  (11.69)     62.78  (11.60)  
Gender  
[units: participants]
     
Female     232     244     476  
Male     1015     1009     2024  



  Outcome Measures
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1.  Primary:   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 ]

2.  Secondary:   Perioperative Complication Rate   [ Time Frame: 30 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Jeff Healey
Organization: Population Health Research Institute, McMaster University
phone: 001 905 330 6760
e-mail: jeff.healey@phri.ca


No publications provided by Boston Scientific Corporation

Publications automatically indexed to this study:

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00800384     History of Changes
Other Study ID Numbers: 11-2007
Study First Received: November 27, 2008
Results First Received: October 13, 2015
Last Updated: January 5, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices