The Leaflex™ Brazilian Standalone Study | NCT05052684

Studies
The Leaflex™ Brazilian Standalone Study

NCT05052684

Sponsor

Pi-cardia

Status

Terminated

Last Update Posted

Nov 20, 2025Actual

Enrollment

1Actual

Phase

Not Applicable

Conditions

Aortic Valve Stenosis

Interventions

Leaflex™ Performer

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Reprioritization of attention and resources by Sponsor

Expanded Access Info

Start Date

Oct 3, 2022Actual

Primary Completion Date

Nov 14, 2024Actual

Completion Date

Nov 14, 2024Actual

First Submitted Date

Sep 9, 2021

First Submission Date that Met QC Criteria

Sep 20, 2021

First Posted Date

Sep 22, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 17, 2025

Last Update Posted Date

Nov 20, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Leaflex™ Performer	Experimental	Intervention with Leaflex™ Performer	Device: Leaflex™ Performer

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Leaflex™ Performer	Device	A transfemoral catheter designed to treat calcific aortic stenosis by scoring the calcification in the aortic valve leaflets.	Leaflex™ Performer

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Hadas Givon	Pi-cardia	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Instituto do Coração FMUSP Centro de Pesquisa		São Paulo		05403-000	Brazil

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001024	Aortic Valve Stenosis

Ancestor Terms

ID	Term
D000082862	Aortic Valve Disease
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases

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Browse Branches

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