The Leaflex™ Standalone Study Protocol

Pi-cardia

Status

Terminated

Conditions

Aortic Valve Stenosis

Treatments

Device: Leaflex™ Performer

Study type

Interventional

Funder types

Industry

Identifiers

NCT04649099

P02-CLN-019

Details and patient eligibility

About

A prospective, multicenter, single-arm 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.

Enrollment

33 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient with symptomatic, severe aortic stenosis who are 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

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.