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The Leaflex™ Brazilian Standalone Study

Primary Purpose

Aortic Valve Stenosis

Status

Recruiting

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Leaflex™ Performer

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Instituto do Coração FMUSP Centro de PesquisaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Leaflex™ Performer

Arm Description

Outcomes

Primary Outcome Measures

Change in aortic valve area

Assessed by echo Assessed by echo

Secondary Outcome Measures

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

Composite

Rate of worsening of aortic regurgitation

By more than 1 grade

Rate of device related adverse events

Change in 6 minute walk test

Distance (meters)

Change in Quality of Life

Kansas City Cardiomyopathy Questionnaire (KCCQ)

Change in Quality of Life

EuroQol- 5 Dimension (EQ5D)

Change in aortic valve area

Assessed by echo

Change in pressure gradients

Assessed by echo

Change in pressure gradients

Measured invasively

Full Information

NCT ID

NCT05052684

First Posted

September 9, 2021

Last Updated

November 8, 2022

Sponsor

Pi-cardia

1. Study Identification

Unique Protocol Identification Number

NCT05052684

Brief Title

The Leaflex™ Brazilian Standalone Study

Official Title

The Leaflex™ Brazilian Standalone Study

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 3, 2022 (Actual)

Primary Completion Date

May 31, 2023 (Anticipated)

Study Completion Date

May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pi-cardia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aortic Valve Stenosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Leaflex™ Performer

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Leaflex™ Performer

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in aortic valve area

Description

Assessed by echo Assessed by echo

Time Frame

Baseline and up to 3 days post procedure

Secondary Outcome Measure Information:

Title

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

Description

Composite

Time Frame

30 days post procedure

Title

Rate of worsening of aortic regurgitation

Description

By more than 1 grade

Time Frame

Baseline and 30 days post procedure

Title

Rate of device related adverse events

Time Frame

Up to 12 months post procedure

Title

Change in 6 minute walk test

Description

Distance (meters)

Time Frame

Baseline, 1, 6 and 12 months post procedure

Title

Change in Quality of Life

Description

Kansas City Cardiomyopathy Questionnaire (KCCQ)

Time Frame

Baseline, 1, 6 and 12 months post procedure

Title

Change in Quality of Life

Description

EuroQol- 5 Dimension (EQ5D)

Time Frame

Baseline, 1, 6 and 12 months post procedure

Title

Change in aortic valve area

Description

Assessed by echo

Time Frame

Baseline, up to 3 days, 30 days, 3, 6, 9 and 12 months post procedure

Title

Change in pressure gradients

Description

Assessed by echo

Time Frame

Baseline, up to 3 days, 30 days, 3, 6, 9 and 12 months post procedure

Title

Change in pressure gradients

Description

Measured invasively

Time Frame

Pre-treatment, immediately post treatment (during procedure)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Merav Gat

Phone

+97289484800

merav@pi-cardia.net

Facility Information:

Facility Name

Instituto do Coração FMUSP Centro de Pesquisa

City

São Paulo

ZIP/Postal Code

05403-000

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alexandre Abizaid, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

The Leaflex™ Brazilian Standalone Study

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