Forsøksdyr: Evaluation of Insertion and Real Time Image Acquisition of Steerable 4D-ICE Catheter in the Acute Animal Model_version_2

Godkjenningsdato 13.11.2018

Godkjenningsperiode 28.11.2018-27.06.2022

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. Benchmark with 2D TEE ultrasound imaging.
Expected damage to research animals:
Up to 3 acute Experiments are planned, and wil be performed in general anesthesia with human endpoints in an operating room at the Intervention Centre at Oslo University Hospital. Expected damage risk is considered to be low, and the clinical team involved has substantial experience with similar preclinical experiments. The system does not contain biohazardous, radioactive, or other hazardous materials.
Expected Scientific outcome:
Intracardiac echocardiography (ICE) 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:
Up to 3 experiments on canine (dog) model.
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. One Experiment is planned primarily to reduce the number Research animals. For administrative purposes the application is made for up to Three research animals in case more than one exoperiment is required. There is no realistic alternative to simulate or replace the planned preclinical in-vivo experiment.