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)
The Leaflex Early Feasibility Study Protocol in Patients with Symptomatic Severe Aortic Stenosis
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
Additional Study Information: This is a prospective, multicenter, non-randomized, single-arm, open-label clinical study, sponsored byPi-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.
Investigator
Susheel Kodali, MD
Do You Qualify?
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
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For more information, please contact:
Kate Dalton
keb2114@cumc.columbia.edu
347-514-3366