MiCLASP PMCF Study
Research type
Research Study
Full title
Transcatheter Repair of Mitral Regurgitation with Edwards PASCAL Transcatheter Valve Repair System: A European prospective, multicenter Post Market Clinical Follow up.
IRAS ID
291725
Contact name
Mamta Buch
Contact email
Sponsor organisation
Edwards Life Sciences
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 7 months, 31 days
Research summary
This is a multi-center, multinational, post-marketing study of a CE marked Device called the PASCAL Transcatheter Valve Repair System used within a routine standard of care setting.
This main purpose of the study will be to collect additional data on routine treatment with the Edwards PASCAL system to expand the available data on the safety and efficacy of this valve repair system in patients with symptomatic mitral valve regurgitation who require mitral valve reconstruction. The patients will be treated with the PASCAL system as per standard practice whether they choose to participate in the study or not.
During this study, data about the participants' health and the results of their medical treatment with the Edwards PASCAL system will be collected and recorded, namely from the time of consent until their discharge from hospital, then after 30 days, after 6 months and then once a year for 5 years after device implantation.
The trial will be conducted in approximately 100 sites in Europe and a maximum of 500 participants will be enrolled. All the participants will be followed for up to 5 years.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
21/WM/0146
Date of REC Opinion
29 Jun 2021
REC opinion
Further Information Favourable Opinion