CALLIOPE Version 1.0
Research type
Research Study
Full title
Clinical Assessment of Essential Remote Monitoring Functions in Pacemakers
IRAS ID
308893
Contact name
Karen Muirhead
Contact email
Sponsor organisation
MicroPort CRM
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 9 months, 31 days
Research summary
Remote monitoring technology has significantly improved the pacemaker’s patient care in hospitals. Patient satisfaction has increased, the number of hospitalisations has decreased and the survival rate among patients implanted with pacing systems has improved.
The pacemakers used in the study are equipped with a Bluetooth low energy wireless technology enabling remote monitoring using a SMARTVIEW CONNECT system so the pacemakers can be monitored from the participants home.
The main focus of the clinical investigation is orientated on the reliability of the electrical measurements via the remote monitoring functions of the cardiac pacing system.
The participants enrolled in this clinical investigation will be followed during 48 months for appropriate performances and safety documentation of the devices.REC name
London - Dulwich Research Ethics Committee
REC reference
22/LO/0006
Date of REC Opinion
28 Feb 2022
REC opinion
Further Information Favourable Opinion