The Leaflex™ Performer Feasibility Study
Research type
Research Study
Full title
A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Clinical Study to Evaluate the Safety and Feasibility of the Leaflex™ Performer (The Leaflex™ Performer Feasibility Study)
IRAS ID
230794
Contact name
Andreas Baumbach
Contact email
Sponsor organisation
Pi-Cardia Ltd.
Duration of Study in the UK
0 years, 4 months, 31 days
Research summary
The Leaflex™ is a ~5mm catheter introduced through the groin to fracture calcium deposits located within the aortic valve leaflets, and in this way to restore the leaflets flexibility and mobility and increase the opening area of the valve. The purpose of this study is to assess the safety, feasibility and performance of the Leaflex™ Performer catheter (Leaflex™) when used for aortic valve repair in patients with severe symptomatic aortic stenosis (narrowing of the aortic valve).
15 patients in up to 5 sites in Europe will be enrolled in the study. Participation time will take approximately 3 months. Data will be collected at baseline, index procedure, pre-discharge from hospital (or at 7 days post procedure, whichever occurs first) and at 30 and 90 days post procedure.
All adverse events 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
17/LO/1519
Date of REC Opinion
3 Nov 2017
REC opinion
Further Information Favourable Opinion