Brief Title
The Leaflex™ Early Feasibility Study
Official Title
A Prospective, Multicenter, Non-randomized, Single-arm, Open-label Clinical Study to Demonstrate the Safety and Performance of the Leaflex™ Performer
Brief Summary
A prospective, multicenter, single-arm, early feasibility study aimed to assess safety and performance of the Leaflex™ Performer in the treatment of patients with symptomatic, severe aortic stenosis. Subjects will be seen at pre- and post procedure, discharge, 30 days and at 3, 6, 9 and 12 months post procedure.
Study Type
Interventional
Primary Outcome
Change in aortic valve area
Secondary Outcome
Rate of all-cause mortality and all-cause stroke (VARC 2)
Condition
Aortic Valve Stenosis
Intervention
Leaflex™ Performer
Study Arms / Comparison Groups
Leaflex™ Performer
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
15
Start Date
June 16, 2021
Completion Date
December 2023
Primary Completion Date
December 2023
Eligibility Criteria
Inclusion Criteria: - Patient with symptomatic, severe aortic stenosis who are operable, but not recommended by the heart team for immediate treatment with surgical or transcatheter aortic valve replacement. - Patient is willing to comply with scheduled visits and tests and is able and willing to provide informed consent. Exclusion Criteria: - Inoperable for emergency surgery. - Moderate or greater aortic regurgitation. - Anatomic contraindications. - Coronary, carotid, or vertebral artery disease that, in the opinion of the heart team, should be treated; or treatment of coronary artery disease ≤ 1 month prior to index procedure. - Aortic balloon valvuloplasty ≤ 3 months prior to index procedure. - Stroke ≤ 12 months prior to index procedure. - History of a myocardial infarction ≤ 6 weeks prior to index procedure. - Patients with clinically significant abnormality in cell blood count, history of bleeding diathesis or coagulopathy. - Hemodynamic instability. - Hypertrophic cardiomyopathy with obstruction. - Left ventricle ejection fraction <30%. - Ongoing severe infection, including endocarditis, or sepsis. - Life expectancy ≤ 12 months.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, +972 89484800, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04636073
Organization ID
P02-CLN-028
Responsible Party
Sponsor
Study Sponsor
Pi-cardia
Study Sponsor
, ,
Verification Date
June 2021