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A Randomised Trial of S-ICD Implantation With and Without Defibrillation Testing - Trial NCT03495297

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.

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NCT03495297
Active, not recruiting
procedure
Trial Details
ClinicalTrials.gov โ€ข NCT03495297
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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

Study Focus

Ventricular Arrythmia

ommitence of defibrillation testing

Interventional

procedure

Sponsor & Location

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Orlando,Atlanta,Chicago,Englewood,New York,New York,Chattanooga,Hamburg,Kiel,Lรผbeck,Mannheim,Wรผrzburg,Almere,Amsterdam,Amsterdam,Dordrecht,Eindhoven,Groningen,Haarlem,Leeuwarden,Nieuwegein,Nijmegen,Zw, Germany,Netherlands,United Kingdom,United States of America

Timeline & Enrollment

N/A

May 07, 2018

Oct 01, 2024

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 tachycardia
Left ventricular failure
Ventricular septal defect
Cardiomyopathy, unspecified
Cardiac arrhythmia, unspecified

Data Source

ClinicalTrials.gov

NCT03495297

Non-Device Trial