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

Completed · Not applicable

Conditions studied: Ventricular Arrythmia

In brief

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.

Key facts

Study ID

NCT03495297

Run by

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

People needed

965

Starts

2018-05-07

Expected to finish

2025-04-01

Last updated by the study team

2026-06-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who meet current guidelines for ICD therapy and intent to undergo a de novo implant procedure for an S-ICD
• Patients must pass S-ICD screening per local routine
• Patients over 18 years of age, willing and capable to give informed consent
• Patients must be willing and capable of complying to follow up visits
• Patient must be eligible for either DFT strategy per physician discretion

You may not qualify if…

• Patient with a life expectancy shorter than 12 months due to any medical condition
• Patients known to be pregnant
• Patients with intracardiac thrombus
• Patients with atrial fibrillation without appropriate anticoagulation
• Patients likely to undergo heart transplant within 12 months
• Patients with LVAD
• Patients with other contra-indications for DFT per physician's discretion

Where it is running

• 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

Full record on ClinicalTrials.gov

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