NCT03495297

A Randomised Trial of S-ICD Implantation With and Without Defibrillation Testing

A Prospective Randomised CompArative Trial of SubcutanEous ImplanTable CardiOverter-DefibrillatoR ImplANtation With and Without DeFibrillation Testing
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)·ClinicalTrials.gov·procedureActive, not recruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Ventricular Arrythmia
Drug/Device/Intervention
ommitence of defibrillation testing
Study type
Interventional
Intervention type
procedure
Sponsor & location
Primary sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Location
Orlando,Atlanta,Chicago,Englewood,New York,New York,Chattanooga,Hamburg,Kiel,Lübeck,Mannheim,Würzburg,Almere,Amsterdam,Amsterdam,Dordrecht,Eindhoven,Groningen,Haarlem,Leeuwarden,Nieuwegein,Nijmegen,Zw, Germany,Netherlands,United Kingdom,United States of America
Timeline & enrollment
Phase
N/A
Start date
May 07, 2018
End date
Oct 01, 2024
Enrollment
965 participants
Primary outcome

Failed first appropriate shock in a spontaneous episode

Summary

This study will test the hypothesis that implantation of a subcutaneous implantable
 cardioverter defibrillator (S-ICD) without performing a defibrillation test is non-inferior
 to S-ICD implant with a defibrillation test with regards to the primary endpoint failed first
 shock in a spontaneous arrhythmia episode when implant position is confirmed with PRAETORIAN
 score.

ICD-10 classifications
Ventricular tachycardiaLeft ventricular failureVentricular septal defectCardiomyopathy, unspecifiedCardiac arrhythmia, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT03495297
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT03495297 through Pure Global AI's free database. This phase not specified trial is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) and is currently Active, not recruiting. The study focuses on Ventricular Arrythmia. Target enrollment is 965 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.