NCT00800384

Shockless Implant Evaluation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,500 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	Implantable defibrillator	Implantable defibrillator to detect and terminate ventricular arrhythmias

Timeline

• Start date: 2009-01-01
• Primary completion: 2013-10-01
• Completion: 2014-05-01
• First posted: 2008-12-02
• Last updated: 2018-03-30
• Results posted: 2015-12-22

Locations

85 sites across 18 countries: Australia, Austria, Canada, Czechia, Finland, France, Germany, Hong Kong, Hungary, Israel, Malaysia, Netherlands, Norway, Poland, Spain, Sweden, Thailand, United Kingdom