PERSEPOLIS
Research type
Research Study
Full title
Prospective Record of Safety and Electrical Performances of XFINE Leads: an International Study
IRAS ID
266166
Contact name
Karen Muirhead
Contact email
Sponsor organisation
Sorin CRM SAS/ Microport CRM
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 2 months, 30 days
Research summary
Leads which connect the pacemaker box to the heart are an essential component of a pacing system. These leads are known to be safe, effective, long lasting and are part of a proven treatment for cardiac disorders such as too slow a pulse. These leads which link the pacemaker box and the cardiac tissue are insulated wires that send electrical impulse to make the heart contact, producing a heartbeat. They traditionally come in two forms dependant on how they fix into the cardiac tissue. One is known an active lead that has a tiny screw-in device at its tip, and the other is a passive lead which has tine fixations which hook into the lining structure inside the heart. The passive leads are available in two shapes at the end - a straight tip and a J-shape tip.
As prompted by regulations, the safety and performance of actively implantable medical devices needs to be monitored after commercial release. Although updates of the literature review and product performance report data are done yearly, Post Market Clinical Follow-up (PMCF) studies are also useful to actively monitor the clinical performances of the product. This clinical investigation can also support the transition from the current Medical Devices Directive 93/42/EU (MDD) to the new Medical Devices Regulation (MDR 2017/745/EU), in order to generate the required level of clinical data in the post-market phase.
Therefore PERSEPOLIS is a post-market study intended to confirm safety and electrical performances of the XFINE lead models over time and up to 12 months.REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
19/LO/1102
Date of REC Opinion
15 Jul 2019
REC opinion
Further Information Favourable Opinion