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The Leaflex™ Early Feasibility Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04636073
Recruitment Status : Recruiting
First Posted : November 19, 2020
Last Update Posted : July 29, 2022
Sponsor:
Information provided by (Responsible Party):
Pi-cardia

Study Description
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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.


Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Device: Leaflex™ Performer Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Non-randomized, Single-arm, Open-label Clinical Study to Demonstrate the Safety and Performance of the Leaflex™ Performer
Actual Study Start Date : June 16, 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in aortic valve area [ Time Frame: Baseline to 3 days ]
    assessed by echo


Secondary Outcome Measures :
  1. Rate of all-cause mortality and all-cause stroke (VARC 2) [ Time Frame: 30 days post procedure ]
    Composite

  2. Rate of worsening of aortic regurgitation [ Time Frame: Baseline to 30 days ]
    by greater than 1 grade

  3. Rate of worsening of aortic regurgitation [ Time Frame: Discharge to 30 days ]
    by greater than 1 grade

  4. Rate of device related adverse events [ Time Frame: 12 months ]
  5. Change in 6 minute walk test [ Time Frame: 1, 6 and 12 months ]
    distance (meters)

  6. Quality of Life Improvement [ Time Frame: 1, 6 and 12 months ]
    measured by KCCQ

  7. Quality of Life Improvement [ Time Frame: 1, 6 and 12 months ]
    measured by EQ5D

  8. Change in aortic valve area [ Time Frame: 30 day, 3, 6, 9, 12 months ]
    assessed by echo

  9. Change in pressure gradients [ Time Frame: 30 day, 3, 6, 9, 12 months ]
    assessed by echo


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04636073


Contacts
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Contact: Merav Gat +972 89484800 merav@pi-cardia.net

Locations
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United States, New Jersey
Atlantic Health System Hospital Corp - Morristown Medical Center Recruiting
Morristown, New Jersey, United States, 07960
United States, New York
Columbia University Medical Center/NYPH Recruiting
New York, New York, United States, 10032
United States, Pennsylvania
UPMC Pinnacle Not yet recruiting
Harrisburg, Pennsylvania, United States, 17101
Sponsors and Collaborators
Pi-cardia
More Information
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Responsible Party: Pi-cardia
ClinicalTrials.gov Identifier: NCT04636073    
Other Study ID Numbers: P02-CLN-028
First Posted: November 19, 2020    Key Record Dates
Last Update Posted: July 29, 2022
Last Verified: July 2022

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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
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Aortic Valve Disease
Heart Valve Diseases
 Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction