The Leaflex™ Brazilian Standalone Study

NCT05052684 | Terminated DMC

• 1 other identifier: P02-CLN-019(BR)
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

• Change in aortic valve area

  Assessed by echo Assessed by echo

  Baseline and up to 3 days post procedure

Secondary Outcomes (9)

• Rate of all-cause mortality and all-cause stroke (VARC 2)

  30 days post procedure

• Rate of worsening of aortic regurgitation

  Baseline and 30 days post procedure

• Rate of device related adverse events

  Up to 12 months post procedure

• Change in 6 minute walk test

  Baseline, 1, 6 and 12 months post procedure

• Change in Quality of Life - KCCQ

  Baseline, 1, 6 and 12 months post procedure

Study Arms (1)

Leaflex™ Performer

EXPERIMENTAL

Intervention with Leaflex™ Performer

Device: Leaflex™ Performer

Interventions

Leaflex™ Performer DEVICE

A transfemoral catheter designed to treat calcific aortic stenosis by scoring the calcification in the aortic valve leaflets.

Leaflex™ Performer

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pi-cardia: lead

Study Sites (1)

Instituto do Coração FMUSP Centro de Pesquisa

São Paulo, 05403-000, Brazil

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Hadas Givon

  Pi-cardia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: September 22, 2021
• Study Start: October 3, 2022
• Primary Completion: November 14, 2024
• Study Completion: November 14, 2024
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)