The Leaflex™ Brazilian Standalone Study

Pi-cardia1 enrolled

Overview

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

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Aortic Valve Stenosis

Interventions

Leaflex™ PerformerDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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.

Locations (1)

Instituto do Coração FMUSP Centro de Pesquisa

São Paulo, Brazil

Outcomes

Primary Outcomes

Change in aortic valve area

Assessed by echo Assessed by echo

Time frame: Baseline and up to 3 days post procedure

Secondary Outcomes

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

Composite

Time frame: 30 days post procedure

Rate of worsening of aortic regurgitation

By more than 1 grade

Time frame: Baseline and 30 days post procedure

Rate of device related adverse events

Percent of patients with device related adverse events

Time frame: Up to 12 months post procedure

Change in 6 minute walk test

Distance (meters)

Time frame: Baseline, 1, 6 and 12 months post procedure

Change in Quality of Life - KCCQ

Kansas City Cardiomyopathy Questionnaire (KCCQ)

Time frame: Baseline, 1, 6 and 12 months post procedure

Change in Quality of Life - EQ5D

EuroQol- 5 Dimension (EQ5D)

Time frame: Baseline, 1, 6 and 12 months post procedure

Change in aortic valve area

Assessed by echo

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

Change in pressure gradients

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.