Status:
COMPLETED
Shockless Implant Evaluation
Lead Sponsor:
Boston Scientific Corporation
Collaborating Sponsors:
Guidant Corporation
Conditions:
Ventricular Fibrillation
Ventricular Tachycardia
Eligibility:
All Genders
18+ years
Phase:
NA
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 cardiove...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Patients undergoing initial implant of an ICD or CRT-D device (can be upgrade from a pacemaker)
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
2500 Patients enrolled
Trial Details
Trial ID
NCT00800384
Start Date
January 1 2009
End Date
May 1 2014
Last Update
March 30 2018
Active Locations (85)
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1
The Royal Melbourne Hospital
Melbourne, Australia, 3050
2
Landesklinikum St. Poelten
Sankt Pölten, Austria, 3100
3
Allgemeines Krankenhaus Wien
Vienna, Austria, 1090
4
Wilhelminenspital
Vienna, Austria, 1160