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The Leaflex™ Brazilian Standalone Study

NCT05052684 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2025-11-20

No results posted yet for this study

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

Interventions

DEVICE

Leaflex™ Performer

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

Sponsors & Collaborators

  • Pi-cardia

    lead INDUSTRY

Principal Investigators

  • Hadas Givon · Pi-cardia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-03
Primary Completion
2024-11-14
Completion
2024-11-14

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05052684 on ClinicalTrials.gov