A Prospective, Multicenter, Non-randomized, Single-arm, Open-label Clinical Study to Demonstrate the Safety and Performance of the Leaflex™ Performer

Pi-cardia0 sites15 target enrollmentJune 1, 2024

Overview

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.

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

June 1, 2024

End Date

June 1, 2024

Last Updated

6 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Pi-cardia

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

Change in aortic valve area

Time Frame: Baseline to 3 days

assessed by echo

Secondary Outcomes

Rate of all-cause mortality and all-cause stroke (VARC 2)(30 days post procedure)
Rate of device related adverse events(12 months)
Rate of worsening of aortic regurgitation(Discharge to 30 days)
Change in 6 minute walk test(1, 6 and 12 months)
Quality of Life Improvement(1, 6 and 12 months)
Change in aortic valve area(30 day, 3, 6, 9, 12 months)
Change in pressure gradients(30 day, 3, 6, 9, 12 months)