The Leaflex™ Standalone Study Protocol

NCT04649099 | Terminated DMC

• 1 other identifier: P02-CLN-019
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective, multicenter, single-arm study aimed to assess safety and performance of the Leaflex™ Performer in the treatment of patients with 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.

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

• Change in aortic valve area

  assessed by echo

  Baseline to 3 days

Secondary Outcomes (8)

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

  30 days post procedure

• Rate of worsening of aortic regurgitation

  Baseline to 30 days

• Rate of device related adverse events

  12 months

• Change in 6 minute walk test

  1, 6 and 12 months

• Quality of Life Improvement

  1, 6 and 12 months

Study Arms (1)

Leaflex™ Performer

EXPERIMENTAL

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+
• 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:

• Moderate or greater 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)

Gottsegen Gyorgy Hungarian Institute of Cardiology

Budapest, Hungary

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

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

Study Design

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

Model Details: The study includes two stages: * Exploratory stage - an exploratory examination of patients with an aim to streamline the study procedures, to reach a safe and consistent result, to evaluate the target patient population and adapt scoring protocol to optimize efficacy of the Leaflex™ procedure. The protocol does not include a formal staticstical analysis of the results of subjects enrolled in this stage. * Confirmatory - confirmatory analysis with an aim to demonstrate the Leaflex™ safety and performance.

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 2, 2020
• Study Start: September 2, 2020
• Primary Completion: November 20, 2023
• Study Completion: August 14, 2024
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)