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Shockless Implant Evaluation

NCT00800384 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2500

Last updated 2018-03-30

Study results available
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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.

Conditions

  • Ventricular Fibrillation
  • Ventricular Tachycardia

Interventions

DEVICE

Implantable defibrillator

Implantable defibrillator to detect and terminate ventricular arrhythmias

Sponsors & Collaborators

  • Guidant Corporation

    collaborator INDUSTRY

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Jeff Healey, MD · Population Health Research Institute Canada

  • Stuart Connolly, MD · Population Health Research Institute Canada

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2013-10-31
Completion
2014-05-31

Countries

  • Australia
  • Austria
  • Canada
  • Czechia
  • Finland
  • France
  • Germany
  • Hong Kong
  • Hungary
  • Israel
  • Malaysia
  • Netherlands
  • Norway
  • Poland
  • Spain
  • Sweden
  • Thailand
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00800384 on ClinicalTrials.gov