Shockless Implant Evaluation (SIMPLE Trial)
Palo Alto (17 mi)Overseen byJeff Healey, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Waitlist Available
Sponsor: Boston Scientific Corporation
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
Treatment Details
2Treatment groups
Experimental Treatment
Active Control
Group I: 1Experimental Treatment1 Intervention
ICD implant without defibrillation testing
Group II: 2Active Control1 Intervention
ICD implant with defibrillation testing
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of Alberta HospitalEdmonton, Canada
Royal Jubilee HospitalVictoria, Canada
St. Boniface General HospitalWinnipeg, Canada
Queen Elizabeth II Health Sciences CenterHalifax, Canada
More Trial Locations
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Who is running the clinical trial?
Boston Scientific CorporationLead Sponsor
Guidant CorporationIndustry Sponsor