The Leaflex™ Standalone Study Protocol

April 3, 2024 updated by: Pi-cardia

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary
        • Gottsegen Gyorgy Hungarian Institute of Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 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:

  • 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pi-cardia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2020

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

November 24, 2020

First Submitted That Met QC Criteria

November 24, 2020

First Posted (Actual)

December 2, 2020

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 3, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P02-CLN-019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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