Aortic Valve StenosisNCT05052684
The Leaflex™ Brazilian Standalone Study
A study testing Leaflex™ Performer in people with Aortic Valve Stenosis, run by Pi-cardia at 1 site in Brazil.
Trial summary
A prospective, multicenter, single-arm study aimed to demonstrate safety and performance of the Leaflex™ Performer in the treatment of symptomatic severe aortic stenosis. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- 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
- 1 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Oct 2022to 14 Nov 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Severe 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto do Coração FMUSP Centro de Pesquisa
São Paulo, 05403-000
About this study
A prospective, multicenter, single-arm study aimed to demonstrate safety and performance of the Leaflex™ Performer in the treatment of symptomatic severe aortic stenosis.
Read the detailed description
A prospective, multicenter, single-arm study aimed to demonstrate safety and performance of the Leaflex™ Performer in the treatment of 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 | Intervention with Leaflex™ Performer 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 Assessed by echo
Measured: Baseline and up to 3 days post procedure
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 more than 1 grade
Measured: Baseline and 30 days post procedure
Rate of device related adverse events
Percent of patients with device related adverse events
Measured: Up to 12 months post procedure
Change in 6 minute walk test
Distance (meters)
Measured: Baseline, 1, 6 and 12 months post procedure
Change in Quality of Life - KCCQ
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Measured: Baseline, 1, 6 and 12 months post procedure
Change in Quality of Life - EQ5D
EuroQol- 5 Dimension (EQ5D)
Measured: Baseline, 1, 6 and 12 months post procedure
Change in aortic valve area
Assessed by echo
Measured: Baseline, up to 3 days, 30 days, 3, 6, 9 and 12 months post procedure
Change in pressure gradients
Assessed by echo
Measured: Baseline, up to 3 days, 30 days, 3, 6, 9 and 12 months post procedure
Change in pressure gradients
Measured invasively
Measured: Pre-treatment, immediately post treatment (during procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start3 Oct 2022
- Primary completion14 Nov 2024
- Study completion14 Nov 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pi-cardia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hadas Givon, Study director, Pi-cardia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05052684
- Sponsor's protocol ID
- P02-CLN-019(BR)
- Status last verified
- Nov 2025
- First submitted
- 9 Sep 2021
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Leaflex™ Brazilian Standalone Study
- ClinicalTrials.gov ID
- NCT05052684
- Acronym / sponsor ID
- P02-CLN-019(BR)
- Conditions
- Aortic Valve Stenosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Reprioritization of attention and resources by Sponsor
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Pi-cardiaIndustry (pharma, biotech, devices)
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 14 Nov 2024 (actual)
- Study completion
- 14 Nov 2024 (actual)
- First posted
- 22 Sep 2021 (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 study aimed to demonstrate safety and performance of the Leaflex™ Performer in the treatment of symptomatic severe aortic stenosis.
Detailed description
A prospective, multicenter, single-arm study aimed to demonstrate safety and performance of the Leaflex™ Performer in the treatment of 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™ PerformerIntervention with Leaflex™ Performer |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (12 listed)
- Severe 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.
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 and up to 3 days post procedure
Assessed by echo 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 and 30 days post procedure
Rate of device related adverse events
Time frame: Up to 12 months post procedure
Change in 6 minute walk test
Time frame: Baseline, 1, 6 and 12 months post procedure
Change in Quality of Life - KCCQ
Time frame: Baseline, 1, 6 and 12 months post procedure
Change in Quality of Life - EQ5D
Time frame: Baseline, 1, 6 and 12 months post procedure
Change in aortic valve area
Time frame: Baseline, up to 3 days, 30 days, 3, 6, 9 and 12 months post procedure
Change in pressure gradients
Time frame: Baseline, up to 3 days, 30 days, 3, 6, 9 and 12 months post procedure
Change in pressure gradients
Time frame: Pre-treatment, immediately post treatment (during procedure)
Results and safety
The study was stopped early (reason given: Reprioritization of attention and resources by Sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Hadas Givon study director
Pi-cardia
1 site in 1 country: see every site and its status.
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 at 1 site in Brazil.
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 12 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: stopped early, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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 stopped early (reason given: Reprioritization of attention and resources by Sponsor). Results are not available in the source record.
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 and up to 3 days post procedure). 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 20 Nov 2025.