The Leaflex™ Brazilian Standalone Study

A prospective, multicenter, single-arm study aimed to demonstrate safety and performance of the Leaflex™ Performer in the treatment of symptomatic severe aortic stenosis.

Study Overview

• Status: Terminated
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Device: Leaflex™ Performer

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 05403-000
    • Instituto do Coração FMUSP Centro de Pesquisa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Leaflex™ Performer; Intervention with Leaflex™ Performer	Device: Leaflex™ Performer; A transfemoral catheter designed to treat calcific aortic stenosis by scoring the calcification in the aortic valve leaflets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in aortic valve area	Assessed by echo Assessed by echo	Baseline and up to 3 days post procedure

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Pi-cardia
• Investigators: Study Director: Hadas Givon, Pi-cardia

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2022
• Primary Completion (Actual): November 14, 2024
• Study Completion (Actual): November 14, 2024

Study Registration Dates

• First Submitted: September 9, 2021
• First Submitted That Met QC Criteria: September 20, 2021
• First Posted (Actual): September 22, 2021

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: P02-CLN-019(BR)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No