Back to resultsThe Leaflex™ Early Feasibility Study
Primary Purpose
Aortic Valve Stenosis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Leaflex™ Performer
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Valve Stenosis
Eligibility Criteria
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.
Sites / Locations
- Atlantic Health System Hospital Corp - Morristown Medical CenterRecruiting
- Columbia University Medical Center/NYPHRecruiting
- UPMC Pinnacle
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 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
measured by KCCQ
Quality of Life Improvement
measured by EQ5D
Change in aortic valve area
assessed by echo
Change in pressure gradients
assessed by echo
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04636073
Brief Title
The Leaflex™ Early Feasibility Study
Official Title
A Prospective, Multicenter, Non-randomized, Single-arm, Open-label Clinical Study to Demonstrate the Safety and Performance of the Leaflex™ Performer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 16, 2021 (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
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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
15 (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 worsening of aortic regurgitation
Description
by greater than 1 grade
Time Frame
Discharge 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
measured by KCCQ
Time Frame
1, 6 and 12 months
Title
Quality of Life Improvement
Description
measured by EQ5D
Time Frame
1, 6 and 12 months
Title
Change in aortic valve area
Description
assessed by echo
Time Frame
30 day, 3, 6, 9, 12 months
Title
Change in pressure gradients
Description
assessed by echo
Time Frame
30 day, 3, 6, 9, 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Merav Gat
Phone
+972 89484800
Email
merav@pi-cardia.net
Facility Information:
Facility Name
Atlantic Health System Hospital Corp - Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Individual Site Status
Recruiting
Facility Name
Columbia University Medical Center/NYPH
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Name
UPMC Pinnacle
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17101
Country
United States
Individual Site Status
Not yet recruiting
12. IPD Sharing Statement
Learn more about this trial
The Leaflex™ Early Feasibility Study
We'll reach out to this number within 24 hrs