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Shockless Implant Evaluation (SIMPLE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Guidant Corporation
ClinicalTrials.gov Identifier:
NCT00800384
First received: November 27, 2008
Last updated: November 12, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Ventricular Fibrillation
Ventricular Tachycardia
 Device: Implantable defibrillator

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Shockless Implant Evaluation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Guidant Corporation:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Complication rate [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 2500
Study Start Date: January 2009
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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 CRT-Ds can be included.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00800384

Locations
Austria
Klinikum Wels - Grieskirchen
Wels, Austria, 4600
Canada
Hôpital Laval
Québec, Canada, G1V 4G5
Germany
Heart Center
Bernau, Germany, 16321
University Hospital Bochum Bergmannsheil
Bochum, Germany, 44789
Klinikum Coburg gGmbH
Coburg, Germany, 96450
Klinikum Kassel
Kassel, Germany, 34125
Klinikum Oldenburg GmbH
Oldenburg, Germany, 26133
Heinrich Braun Krankenhaus
Zwickau, Germany, 08060
Sponsors and Collaborators
Guidant Corporation
Boston Scientific Corporation
Investigators
Principal Investigator: Jeff Healey, MD Population Health Research Institute Canada
Study Chair: Stuart Connolly, MD Population Health Research Institute Canada
  More Information

No publications provided

Responsible Party: Guidant Corporation
ClinicalTrials.gov Identifier: NCT00800384     History of Changes
Other Study ID Numbers: 11-2007
Study First Received: November 27, 2008
Last Updated: November 12, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Tachycardia
Ventricular Fibrillation
Tachycardia, Ventricular
Arrhythmias, Cardiac
 Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013