Forsøksdyr: Validation of a combined epicardial pacemaker and cardiac motion sensor for heart function assessment in a closed thorax

Godkjenningsdato 12.03.2018

Godkjenningsperiode 12.03.2018-11.03.2022

Validation of a combined epicardial pacemaker and cardiac motion sensor for
heart function assessment in a closed thorax
I. The purpose of the experiment/project:
The objective of this explorative longitudinal study is to demonstrate safety and performance of Cardisense, a new platform for cardiac monitoring. Features of Cardisense combine an epicardial pacemaker electrode and a motion sensor (accelerometer). The system is to be tested in an animal model before entering a human study. This is a preparatory part of the CE-marking process of the device.
II. The expected adverse effects on the animals:
The experiments will be performed as acute terminal experiments in general anesthesia. Criteria for human end points will be used, and signs of too low anesthesia depth will be immediately corrected. Hypo-, or hyperthermia as well as ventilator or circulatory instability will be promptly corrected during all phases of experiments.
III. The expected scientific benefits or benefits for society:
The goal is to validate cardiac motion detection and assess efficacy in use of Cardisense. It is expected to prove clinically that no unwanted complications as abnormal bleeding occurs during placement and removal occurs by use of the system compared to standard epicardial pacemaker electrode removal. A final product will facilitate better and more specific monitoring of patients undergoing cardiac surgery.
IV. The number of animals and species:
The experiments with use of up to 20 pigs is a pilot project where all animals serve as own controls. The number of animals will be reduced if possible based on study outcome in case data collection meets the end point criteria before expected.
V. How will the requirements for 3R be accomplished by the experiment/project:
The clinical outcome data from the experiments cannot be replaced neither by simulation or reproduced in any other fashion which justifies the actual research animal model which is considered closest to human application.
Due to long experience and expertise of the clinical group performing the experiments adverse events related to the surgical procedure are expected to be avoided and thereby reduce the number of animals to a minimum.
The research animals will get general anesthesia during the whole experiment, and will not experience pain or discomfort at any time during the surgical procedure.