The Leaflex Catheter System FIM Study
Research type
Research Study
Full title
A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Clinical Study to Evaluate the Safety and Performance of the Leaflex™ Catheter System (The Leaflex™ FIM Study)
IRAS ID
134078
Contact name
Martyn Thomas
Contact email
Sponsor organisation
Pi-Cardia Ltd,
Research summary
This is a prospective, multicenter, non-randomised, single-arm, open-label first in man clinical study, sponsored by Pi-Cardia. 15 patients will be treated with the Leaflex™ Catheter System in up to 5 sites in Europe and Australia. Patients who meet all eligibility criteria and have signed the informed consent are eligible for this study and will undergo the Leaflex Catheter System procedure. Data will be collected at baseline, procedure,pre-discharge, 1, 3, 6, 12, 18 and 24 months. All adverse events, including deaths, will be collected throughout the course of the study. Results of all patients undergoing the procedure will be collected, analyzed and reported.
REC name
London - Dulwich Research Ethics Committee
REC reference
13/LO/1435
Date of REC Opinion
28 Nov 2013
REC opinion
Further Information Favourable Opinion