The Leaflex™ Standalone Study Protocol

Not Applicable

Terminated

• Conditions: Aortic Valve Stenosis
• Interventions: Device: Leaflex™ Performer

• Registration Number: NCT04649099
• Lead Sponsor: Pi-cardia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-02
• Study First Submitted: 2020-11-24
• Study First Submitted QC: 2020-11-24
• Study First Posted: 2020-12-02
• Primary Completion: 2023-11-20
• Study Completion: 2024-08-14
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 33

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Leaflex™ Performer	Leaflex™ Performer	-

Primary Outcome Measures

Name	Time	Method
Change in aortic valve area	Baseline to 3 days	assessed by echo

Secondary Outcome Measures

Name	Time	Method
Rate of device related adverse events	12 months
Quality of Life Improvement	1, 6 and 12 months	EQ5D
Change in aortic valve area	30 days, 3, 6, 9 and 12 months	assessed by echo
Rate of all-cause mortality and all-cause stroke (VARC 2)	30 days post procedure	Composite
Change in 6 minute walk test	1, 6 and 12 months	distance (meters)
Change in pressure gradients	30 days, 3, 6, 9 and 12 months	assessed by echo
Rate of worsening of aortic regurgitation	Baseline to 30 days	by greater than 1 grade

Trial Locations

Locations (1)

Gottsegen Gyorgy Hungarian Institute of Cardiology; 🇭🇺 Budapest, Hungary