Shockless Implant Evaluation

Boston Scientific Corporation85 sites in 7 countries2,500 target enrollmentJanuary 2009

ConditionsVentricular Fibrillation Ventricular Tachycardia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Ventricular Fibrillation
Sponsor: Boston Scientific Corporation
Enrollment: 2500
Locations: 85
Primary Endpoint: First Occurrence of the Composite of Failed First Appropriate Clinical Shock From the Implantable Cardioverter Defibrillator (ICD) or Arrhythmic Death
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2009

End Date

May 2014

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Boston Scientific Corporation

Responsible Party

Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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.