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The Leaflex™ Standalone Study Protocol

Primary Purpose

Aortic Valve Stenosis

Status
Recruiting
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
Leaflex™ Performer
Sponsored by
Pi-cardia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis

Eligibility Criteria

18 Years - undefined (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:

  • 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.

Sites / Locations

  • Gottsegen Gyorgy Hungarian Institute of CardiologyRecruiting

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

Secondary Outcome Measures

Rate of all-cause mortality and all-cause stroke (VARC 2)
Composite
Rate of worsening of aortic regurgitation
by greater than 1 grade
Rate of device related adverse events
Change in 6 minute walk test
distance (meters)
Quality of Life Improvement
KCCQ
Quality of Life Improvement
EQ5D
Change in aortic valve area
assessed by echo
Change in pressure gradients
assessed by echo

Full Information

First Posted
November 24, 2020
Last Updated
March 27, 2023
Sponsor
Pi-cardia
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1. Study Identification

Unique Protocol Identification Number
NCT04649099
Brief Title
The Leaflex™ Standalone Study Protocol
Official Title
The Leaflex™ Standalone Study Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 2, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

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
80 (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
Time Frame
Baseline to 3 days
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 greater than 1 grade
Time Frame
Baseline to 30 days
Title
Rate of device related adverse events
Time Frame
12 months
Title
Change in 6 minute walk test
Description
distance (meters)
Time Frame
1, 6 and 12 months
Title
Quality of Life Improvement
Description
KCCQ
Time Frame
1, 6 and 12 months
Title
Quality of Life Improvement
Description
EQ5D
Time Frame
1, 6 and 12 months
Title
Change in aortic valve area
Description
assessed by echo
Time Frame
30 days, 3, 6, 9 and 12 months
Title
Change in pressure gradients
Description
assessed by echo
Time Frame
30 days, 3, 6, 9 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Merav Gat
Phone
+97289484800
Email
merav@pi-cardia.net
Facility Information:
Facility Name
Gottsegen Gyorgy Hungarian Institute of Cardiology
City
Budapest
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Andreka, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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The Leaflex™ Standalone Study Protocol

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