The Leaflex™ Early Feasibility Study

A Prospective, Multicenter, Non-randomized, Single-arm, Open-label Clinical Study to Demonstrate the Safety and Performance of the Leaflex™ Performer

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

Study Overview

• Status: Withdrawn
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Device: Leaflex™ Performer

Detailed Description

A prospective, multicenter, single-arm, early feasibility 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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Atlantic Health System Hospital Corp - Morristown Medical Center
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center/NYPH
  • Pennsylvania
    • Harrisburg, Pennsylvania, United States, 17101
      • UPMC Pinnacle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient with symptomatic, severe aortic stenosis who are operable, but 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:

• Inoperable for emergency surgery.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Leaflex™ Performer	Device: Leaflex™ Performer; A transfemoral catheter designed to treat calcific aortic stenosis by scoring the calcification in the aortic valve leaflets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in aortic valve area	assessed by echo	Baseline to 3 days

Secondary Outcome Measures

Outcome Measure	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 greater than 1 grade	Baseline to 30 days
Rate of device related adverse events		12 months
Change in 6 minute walk test	distance (meters)	1, 6 and 12 months
Rate of worsening of aortic regurgitation	by greater than 1 grade	Discharge to 30 days
Quality of Life Improvement	measured by KCCQ	1, 6 and 12 months
Quality of Life Improvement	measured by EQ5D	1, 6 and 12 months
Change in aortic valve area	assessed by echo	30 day, 3, 6, 9, 12 months
Change in pressure gradients	assessed by echo	30 day, 3, 6, 9, 12 months

Collaborators and Investigators

• Sponsor: Pi-cardia

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Actual): June 1, 2024
• Study Completion (Actual): June 1, 2024

Study Registration Dates

• First Submitted: October 30, 2020
• First Submitted That Met QC Criteria: November 14, 2020
• First Posted (Actual): November 19, 2020

Study Record Updates

• Last Update Posted (Estimated): October 27, 2025
• Last Update Submitted That Met QC Criteria: October 23, 2025
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: P02-CLN-028

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes