A prospective, multicenter, non-randomized, single-arm, open-label clinical study to demonstrate the safety and performance of the Leaflex Performer (The Leaflex Early Feasibility Study)
Sponsor: |
Pi-Cardia |
Enrolling: |
Male and Female Patients |
Clinic Visits: |
5 |
IRB Number: |
AAAT4776 |
U.S. Govt. ID: |
NCT04636073 |
Contact: |
Kate Dalton: 347-514-3366 / keb2114@cumc.columbia.edu |
This is a prospective, multicenter, non-randomized, single-arm, open-label clinical study, sponsored by Pi-Cardia. Fifteen (15) patients with symptomatic severe Aortic Stenosis (narrowing of the aortic valve) who are considered operable but are not recommended by the heart team for immediate treatment with surgical or transcatheter aortic valve replacement will be treated with the Leaflex Performer in up to 7 clinical sites. All enrolled patients will be followed up at 30 days and at 3, 6, 9, and 12 months post-procedure.
This study is closed
Investigator
Susheel Kodali, MD
Are you 18 years or older? |
Yes |
No |
Are you willing to return to Columbia University Medical Center for all research required follow up visits? |
Yes |
No |
Do you have a peptic ulcer? |
Yes |
No |