The Leaflex™ Early Feasibility Study
Not Applicable
Withdrawn
- Conditions
- Aortic Valve Stenosis
- Interventions
- Device: Leaflex™ Performer
- Registration Number
- NCT04636073
- Lead Sponsor
- Pi-cardia
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- 15
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Leaflex™ Performer Leaflex™ Performer -
- Primary Outcome Measures
Name Time Method Change in aortic valve area Baseline to 3 days assessed by echo
- Secondary Outcome Measures
Name Time Method Rate of all-cause mortality and all-cause stroke (VARC 2) 30 days post procedure Composite
Rate of device related adverse events 12 months Rate of worsening of aortic regurgitation Discharge to 30 days by greater than 1 grade
Change in 6 minute walk test 1, 6 and 12 months distance (meters)
Quality of Life Improvement 1, 6 and 12 months measured by EQ5D
Change in aortic valve area 30 day, 3, 6, 9, 12 months assessed by echo
Change in pressure gradients 30 day, 3, 6, 9, 12 months assessed by echo
Trial Locations
- Locations (3)
Atlantic Health System Hospital Corp - Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
Columbia University Medical Center/NYPH
🇺🇸New York, New York, United States
UPMC Pinnacle
🇺🇸Harrisburg, Pennsylvania, United States