NCT04649099TerminatedNot Applicable
The Leaflex™ Standalone Study Protocol
Pi-cardia1 site in 1 country33 target enrollmentStarted: September 2, 2020Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Change in aortic valve area
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Leaflex™ Performer
Experimental
Intervention: Leaflex™ Performer (Device)
Outcomes
Primary Outcomes
Change in aortic valve area
Time Frame: Baseline to 3 days
assessed by echo
Secondary Outcomes
- Rate of device related adverse events(12 months)
- Change in 6 minute walk test(1, 6 and 12 months)
- Quality of Life Improvement(1, 6 and 12 months)
- Change in aortic valve area(30 days, 3, 6, 9 and 12 months)
- Rate of all-cause mortality and all-cause stroke (VARC 2)(30 days post procedure)
- Change in pressure gradients(30 days, 3, 6, 9 and 12 months)
- Rate of worsening of aortic regurgitation(Baseline to 30 days)
Investigators
Study Sites (1)
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