42
Participants
Start Date
November 29, 2018
Primary Completion Date
April 1, 2022
Study Completion Date
April 1, 2022
commercially released subcutaneous implantable cardioverter defibrillator (S-ICD) and the Investigational S-ICD Adapter.
The S-ICD System is a Subcutaneous (under the skin) Implantable Cardioverter Defibrillator for people who are at risk of Sudden Cardiac Arrest. A new electrode configuration will be tested for Defibrillation testing ( DFT). The unit of measure will be in Joules. VF will be induced and the device will deliver a shock at a certain defined energy level as described in the protocol
Academisch Medisch Centrum, Amsterdam
St. Antonius Ziekenhuis, Nieuwegein
Erasmus MC - University Medical Center Rotterdam, Rotterdam
Isala Klinieken, Zwolle
Lead Sponsor
Boston Scientific Corporation
INDUSTRY