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A Randomised Trial of S-ICD Implantation With and Without Defibrillation Testing
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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.
Official title: A Prospective Randomised CompArative Trial of SubcutanEous ImplanTable CardiOverter-DefibrillatoR ImplANtation With and Without DeFibrillation Testing
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
965
Start Date
2018-05-07
Completion Date
2025-07
Last Updated
2025-02-03
Healthy Volunteers
No
Conditions
Interventions
ommitence of defibrillation testing
Induction of a ventricular arrhythmia to test proper arrhythmia detection and termination by the implanted device is omitted
Locations (32)
Adventh Health System
Orlando, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
CorVita Science Foundation
Chicago, Illinois, United States
Englewood Hospital and Medical Center
Englewood, New Jersey, United States
Mount Sinai Beth Israel
New York, New York, United States
Icahn School of Medicine at Mount Sinaï
New York, New York, United States
Erlanger Health System
Chattanooga, Tennessee, United States
Asklepios Kliniken
Hamburg, Germany
Universitätsklinikum Schleswig-Holstein
Kiel, Germany
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Lübeck, Germany
Universitätsklinikum Mannheim
Mannheim, Germany
Universitätsklinikum Würzburg
Würzburg, Germany
Flevoziekenhuis
Almere Stad, Netherlands
Academic Medical Center Amsterdam
Amsterdam, Netherlands
OLVG
Amsterdam, Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht, Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands
UMCG
Groningen, Netherlands
Spaarne Gasthuis
Haarlem, Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, Netherlands
St Antonius Ziekenhuis
Nieuwegein, Netherlands
Canisius Wilhelmina Ziekenhuis
Nijmegen, Netherlands
Isala Klinieken
Zwolle, Netherlands
Basildon and Thurrock Univerity Hospital NHS Foundation Trust
Basildon, United Kingdom
Blackpool Victoria Hospital NHS Foundation Trust
Blackpool, United Kingdom
Royal Papworth Hospital NHS Foundation Trust
Cambridge, United Kingdom
Heart and Chest Hospital NHS Foundation Trust
Liverpool, United Kingdom
Barts Health NHS Trust of the Royal London Hospital
London, United Kingdom
Manchester Heart Center, Manchester Royal Infirmary
Manchester, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust, Northern General Hospital
Sheffield, United Kingdom
The Royal Wolverhampton NHS Trust, the New Cross Hospital
Wolverhampton, United Kingdom