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NCT03495297 · ClinicalTrials.gov registry record · NA
A Randomised Trial of S-ICD Implantation With and Without Defibrillation Testing
A NA study of Ventricular Arrythmia, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
- Active
- Registry status
- NA
- Development phase
- 965
- Enrollment target
- 20
- Study locations
NCT03495297 is a NA study of Ventricular Arrythmia that is active but no longer recruiting, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). The registered enrollment target is 965 participants, below the 2,962-participant average among 3 other Ventricular Arrythmia trials with a reported enrollment target (67% lower). The trial reports 20 study locations across 7 states.
The verdict
NCT03495297, a NA study of Ventricular Arrythmia, is active but no longer recruiting, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 965 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- PROCEDURE ommitence of defibrillation testing
Study Locations (20)
Other
- Asklepios Kliniken - Hamburg
- Universitätsklinikum Schleswig-Holstein - Kiel
- Universitätsklinikum Schleswig-Holstein, Campus Lübeck - Lübeck
- Universitätsklinikum Mannheim - Mannheim
- Universitätsklinikum Würzburg - Würzburg
- Flevoziekenhuis - Almere Stad
- Academic Medical Center Amsterdam - Amsterdam
- OLVG - Amsterdam
- Albert Schweitzer Ziekenhuis - Dordrecht
- Catharina Ziekenhuis - Eindhoven
- UMCG - Groningen
- Spaarne Gasthuis - Haarlem
- Medisch Centrum Leeuwarden - Leeuwarden
New York
- Mount Sinai Beth Israel - New York
- Icahn School of Medicine at Mount Sinaï - New York
Florida
- Adventh Health System - Orlando
Georgia
- Emory University Hospital - Atlanta
Illinois
- CorVita Science Foundation - Chicago
New Jersey
- Englewood Hospital and Medical Center - Englewood
Tennessee
- Erlanger Health System - Chattanooga
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 965 participants |
| Start Date | 2018-05-07 |
| Est. Completion | 2025-07 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03495297
The ClinicalTrials.gov registry entry for NCT03495297 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 965 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,962-participant average among 3 other Ventricular Arrythmia trials with a reported enrollment target (67% lower). The listed sponsor is Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), which has 8 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Ventricular Arrythmia appearing as the primary indexed condition, and to 1 intervention - of which ommitence of defibrillation testing is the first listed.
NCT03495297 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Other, New York, Florida.
Frequently Asked Questions
What is clinical trial NCT03495297 about?
NCT03495297 is a clinical study titled "A Randomised Trial of S-ICD Implantation With and Without Defibrillation Testing". 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 arrhyth...
What is the current status of trial NCT03495297?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 965 participants. The study started on 2018-05-07. Estimated completion is 2025-07.
What conditions does trial NCT03495297 study?
This clinical trial studies the following conditions: Ventricular Arrythmia.
What interventions are being tested in trial NCT03495297?
The interventions under investigation include: ommitence of defibrillation testing (PROCEDURE).
Who is sponsoring clinical trial NCT03495297?
This trial is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03495297 being conducted?
This trial has 20 study locations across Florida, Georgia, Illinois, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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