
Co-ordinator
Approval to start clinical investigation obtained in Norway and Denmark
We are happy to announce that approvals have now been granted from both Norwegian and Danish competent authorities (Statens Legemiddelverk and Lægemiddelstyrelsen) for the SAMBAfun clinical study "A multicenter, international, open clinical investigation to evaluate the performance of a temporary epicardial pace wire with integrated sensor for continuous postoperative monitoring of myocardial function after heart surgery compared to ultrasound."
This means we are on track to enroll the first patients in August/September. This represents an important milestone both for Cardiaccs and the SAMBAfun project.