Study Stopped
Reprioritization of attention and resources by Sponsor.
The Leaflex™ Early Feasibility Study
A Prospective, Multicenter, Non-randomized, Single-arm, Open-label Clinical Study to Demonstrate the Safety and Performance of the Leaflex™ Performer
1 other identifier
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2024
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2020
CompletedFirst Posted
Study publicly available on registry
November 19, 2020
CompletedStudy Start
First participant enrolled
June 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedOctober 27, 2025
May 1, 2024
Same day
October 30, 2020
October 23, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change in aortic valve area
assessed by echo
Baseline to 3 days
Secondary Outcomes (9)
Rate of all-cause mortality and all-cause stroke (VARC 2)
30 days post procedure
Rate of worsening of aortic regurgitation
Baseline to 30 days
Rate of worsening of aortic regurgitation
Discharge to 30 days
Rate of device related adverse events
12 months
Change in 6 minute walk test
1, 6 and 12 months
- +4 more secondary outcomes
Study Arms (1)
Leaflex™ Performer
EXPERIMENTALInterventions
A transfemoral catheter designed to treat calcific aortic stenosis by scoring the calcification in the aortic valve leaflets.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pi-cardialead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2020
First Posted
November 19, 2020
Study Start
June 1, 2024
Primary Completion
June 1, 2024
Study Completion
June 1, 2024
Last Updated
October 27, 2025
Record last verified: 2024-05