The Leaflex™ Early Feasibility Study

Pi-cardia

Status

Withdrawn

Conditions

Aortic Valve Stenosis

Treatments

Device: Leaflex™ Performer

Study type

Interventional

Funder types

Industry

Identifiers

NCT04636073

P02-CLN-028

Details and patient eligibility

About

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.

Full description

Subjects will be seen at pre- and post procedure, discharge, 30 days and at 3, 6, 9 and 12 months post procedure.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.