Aortic Valve StenosisNCT04636073
The Leaflex™ Early Feasibility Study
A study testing Leaflex™ Performer in people with Aortic Valve Stenosis, run by Pi-cardia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Leaflex™ Performer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
About this study
Official title: A Prospective, Multicenter, Non-randomized, Single-arm, Open-label Clinical Study to Demonstrate the Safety and Performance of the Leaflex™ Performer
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.
Read the detailed description
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.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Leaflex™ Performer
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leaflex™ PerformerDevice
A transfemoral catheter designed to treat calcific aortic stenosis by scoring the calcification in the aortic valve leaflets.
| Study group | Role | What they receive |
|---|---|---|
| Leaflex™ Performer | Experimental | Not described Receives: Device: Leaflex™ Performer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in aortic valve area
assessed by echo
Measured: Baseline to 3 days
Secondary outcomes (9)
Rate of all-cause mortality and all-cause stroke (VARC 2)
Composite
Measured: 30 days post procedure
Rate of worsening of aortic regurgitation
by greater than 1 grade
Measured: Baseline to 30 days
Rate of worsening of aortic regurgitation
by greater than 1 grade
Measured: Discharge to 30 days
Rate of device related adverse events
Measured: 12 months
Change in 6 minute walk test
distance (meters)
Measured: 1, 6 and 12 months
Quality of Life Improvement
measured by KCCQ
Measured: 1, 6 and 12 months
Quality of Life Improvement
measured by EQ5D
Measured: 1, 6 and 12 months
Change in aortic valve area
assessed by echo
Measured: 30 day, 3, 6, 9, 12 months
Change in pressure gradients
assessed by echo
Measured: 30 day, 3, 6, 9, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start1 Jun 2024
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Why it stopped: Reprioritization of attention and resources by Sponsor.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pi-cardia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04636073
- Sponsor's protocol ID
- P02-CLN-028
- Status last verified
- May 2024
- First submitted
- 30 Oct 2020
- Last updated
- 27 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Non-randomized, Single-arm, Open-label Clinical Study to Demonstrate the Safety and Performance of the Leaflex™ Performer
- ClinicalTrials.gov ID
- NCT04636073
- Acronym / sponsor ID
- P02-CLN-028
- Conditions
- Aortic Valve Stenosis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Reprioritization of attention and resources by Sponsor.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Pi-cardiaIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 19 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Leaflex™ Performer | Experimental | Device: Leaflex™ Performer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leaflex™ PerformerA transfemoral catheter designed to treat calcific aortic stenosis by scoring the calcification in the aortic valve leaflets. | Device | Leaflex™ Performer |
Primary outcome
Change in aortic valve area
Time frame: Baseline to 3 days
assessed by echo
9 secondary outcomes
Rate of all-cause mortality and all-cause stroke (VARC 2)
Time frame: 30 days post procedure
Rate of worsening of aortic regurgitation
Time frame: Baseline to 30 days
Rate of worsening of aortic regurgitation
Time frame: Discharge to 30 days
Rate of device related adverse events
Time frame: 12 months
Change in 6 minute walk test
Time frame: 1, 6 and 12 months
Quality of Life Improvement
Time frame: 1, 6 and 12 months
Quality of Life Improvement
Time frame: 1, 6 and 12 months
Change in aortic valve area
Time frame: 30 day, 3, 6, 9, 12 months
Change in pressure gradients
Time frame: 30 day, 3, 6, 9, 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Leaflex™ Performer in people with Aortic Valve Stenosis, run by Pi-cardia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in aortic valve area (time frame: Baseline to 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2025.