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
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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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Experimental: Leaflex™ Performer||
Device: Leaflex™ Performer
A transfemoral catheter designed to treat calcific aortic stenosis by scoring the calcification in the aortic valve leaflets.
- Change in aortic valve area [ Time Frame: Baseline to 3 days ]assessed by echo
- Rate of all-cause mortality and all-cause stroke (VARC 2) [ Time Frame: 30 days post procedure ]Composite
- Rate of worsening of aortic regurgitation [ Time Frame: Baseline to 30 days ]by greater than 1 grade
- Rate of worsening of aortic regurgitation [ Time Frame: Discharge to 30 days ]by greater than 1 grade
- Rate of device related adverse events [ Time Frame: 12 months ]
- Change in 6 minute walk test [ Time Frame: 1, 6 and 12 months ]distance (meters)
- Quality of Life Improvement [ Time Frame: 1, 6 and 12 months ]measured by KCCQ
- Quality of Life Improvement [ Time Frame: 1, 6 and 12 months ]measured by EQ5D
- Change in aortic valve area [ Time Frame: 30 day, 3, 6, 9, 12 months ]assessed by echo
- Change in pressure gradients [ Time Frame: 30 day, 3, 6, 9, 12 months ]assessed by echo
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
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
|Contact: Merav Gat||+972 firstname.lastname@example.org|
|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|
|Other Study ID Numbers:||
|First Posted:||November 19, 2020 Key Record Dates|
|Last Update Posted:||July 29, 2022|
|Last Verified:||July 2022|
|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|
Aortic Valve Stenosis
Aortic Valve Disease
Heart Valve Diseases
Ventricular Outflow Obstruction