The Leaflex™ Early Feasibility Study

Purpose

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.

Condition

  • Aortic Valve Stenosis

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Leaflex™ Performer
  • Device: Leaflex™ Performer
    A transfemoral catheter designed to treat calcific aortic stenosis by scoring the calcification in the aortic valve leaflets.

Recruiting Locations

Atlantic Health System Hospital Corp - Morristown Medical Center
Morristown, New Jersey 07960

Columbia University Medical Center/NYPH
New York, New York 10032

More Details

NCT ID
NCT04636073
Status
Recruiting
Sponsor
Pi-cardia

Study Contact

Merav Gat
+972 89484800
merav@pi-cardia.net