Forsøksdyr: Evaluation of Insertion and Real Time Image Acquisition of Steerable 4D-ICE Catheter in the Acute Animal Model

Godkjenningsdato 22.05.2018

To insert and evaluate a Steerable 4D-ICE (Intracardiac Echocardiography) catheter in the acute animal model, and to evaluate imaging and software integration for 4D image acquisition and transfer of image files for diagnostic usefulness and software evaluation. Demonstrate a fully functional device.
Expected damage to research animals:
Only one acute experiment is planned, and wil be performed in general anesthesia with human endpoints in an operating room at the Intervention Centre. Expected damage risk is considered to be low, and the clinical team involved has long experience with similar preclinical Experiments. The system does not contain biohazardous, radioactive, or other hazardous materials.
Expected Scientific outcome:
Intracardiac Echo is a standard technology which enables diagnostic image acquisition in positioning and steering catheters in the right and left side of the heart. The technology evaluated in this protocol is designed to provide real-time 3D (4D) diagnostic imaging for the guidance and positioning of catheters within the left and right side of the heart. With an increase in catheter based technologies for the treatment of structural diseases, advanced imaging becomes even more critical.
Number of animals:
One Experiment will be performed on a pig (Sus scrofa domesticus).
Replacement, reduction and refinement:
The acute preclinical experiment is instrumental in the exploration of the Steerable 4D-ICE catheter, and is required before human application. There will be one Experiment only to reduce the number Research animals. there is no realistic alternative to simulate or replace the planned preclinical in-vivo experiment.