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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.