The Leaflex™ Brazilian Standalone Study

Not Applicable

Terminated

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

• Registration Number: NCT05052684
• Lead Sponsor: Pi-cardia

Brief Summary

A prospective, multicenter, single-arm study aimed to demonstrate safety and performance of the Leaflex™ Performer in the treatment of 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 First Submitted: 2021-09-09
• Study First Submitted QC: 2021-09-20
• Study First Posted: 2021-09-22
• Study Start: 2022-10-03
• Status Verified: 2024-04
• Primary Completion: 2024-11-14
• Study Completion: 2024-11-14
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

• Severe 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 and up to 3 days post procedure	Assessed by echo Assessed by echo

Secondary Outcome Measures

Name	Time	Method
Rate of device related adverse events	Up to 12 months post procedure
Change in aortic valve area	Baseline, up to 3 days, 30 days, 3, 6, 9 and 12 months post procedure	Assessed by echo
Change in pressure gradients	Pre-treatment, immediately post treatment (during procedure)	Measured invasively
Rate of worsening of aortic regurgitation	Baseline and 30 days post procedure	By more than 1 grade
Change in 6 minute walk test	Baseline, 1, 6 and 12 months post procedure	Distance (meters)
Rate of all-cause mortality and all-cause stroke (VARC 2)	30 days post procedure	Composite
Change in Quality of Life	Baseline, 1, 6 and 12 months post procedure	EuroQol- 5 Dimension (EQ5D)

Trial Locations

Locations (1)

Instituto do Coração FMUSP Centro de Pesquisa; 🇧🇷 São Paulo, Brazil