Pre-Clinical Assessment of 4D Micro TEE and 4D ICE probes

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1 Objectives
Firstly an experiment will be conducted to investigate performance of a novel TEE(transesophageal echo) probe, called the 4D Micro TEE probe mounted on a steerable cahteter intended for use on pediatric patients. Secondly an experiment will investigate performance of a new 4D ICE (intra cardiac echo) probe, intended for young adult patients. The 4D ICE Catheter is a pre market device not approved for human use.The experiment cannot be made on patients or volunteers for ethical reasons. The experiment in the current model is critical to gain results and experience to prepare for first in human studies in order to obtain regulatory approval of the 4D ICE catheter as a medical device for human application.
2 Expected damage to reserach animals
Two acute experiments are planned, with three optional animal experiments to reach study terminal end points. Experiments will be performed in general anesthesia with appropriate human end points in an operating room designed for human use at The Intervention Centre, Oslo University Hospital. Expected damage risk is considered to be low, and the clinical team involved has substantial experience with similar preclinical experiments. The experimental medical devices does not contain biohazardous, radioactive or hazardous materials.

3 Expected scientific outcome
This study will enable iterative optimization of transesophageal imaging and intra cardiac echo imaging settings (such as waveform transmission, aperture control, and user presets), and facilitate the collection of image data for future research to improve image quality and other aspects of development. Preclinical data is the first step in ensuring optimal image quality for new TEE probes, and there are no viable non-animal models in which this research can be performed. Outcomes will be used to develop catheter based technologies for treatment of structural diseases based on advanced imaging. 4D ICE probes are expected to replace current 2D ICE probes.
The primary endpoint is objective feedback from clinical experts structured in a case report form (CRF) after use of a) 4D micro TEE probe and comparator probes and b) use of the 4D ICE probe on Vivid E95 and Vivid S70n ultrasound systems.

4 Number and species of animals
Experiments to test the Micro 4D TEE will be made on a 5kg piglet model with a size complying with pediatric patients.
Tests of the 4D ICE technology requires a canine model for adequate evaluation of image aquisition and positioning related to structural elements of the heart as close as possible to young adult humans.

5 Compliance to 3R
To optimize live images, simulation data and phantom images are not adequate. Optimization of TEE and ICE will require advanced non-invasive and invasive procedures. It is unethical to conduct optimization studies in humans due to potential risks associated with extension or complication of invasive ultrasound techniques. Porcine and Canine models have similar anatomical structures to humans, making porcine and canine preclinical models optimal for optimization of TEE and ICE in vivo prior to clinical testing. There is no realistic alternative to simulate, reduce, refine or replace the planned experiments..