Aortic Valve StenosisNCT04649099
The Leaflex™ Standalone Study Protocol
A study testing Leaflex™ Performer in people with Aortic Valve Stenosis, run by Pi-cardia at 1 site in Hungary.
Trial 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. 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
- 33 participants
- Where
- 1 siteHungary
- Study dates
- 2 Sep 2020to 14 Aug 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 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
- 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.
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.
About this study
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.
- 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 (8)
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 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
KCCQ
Measured: 1, 6 and 12 months
Quality of Life Improvement
EQ5D
Measured: 1, 6 and 12 months
Change in aortic valve area
assessed by echo
Measured: 30 days, 3, 6, 9 and 12 months
Change in pressure gradients
assessed by echo
Measured: 30 days, 3, 6, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start2 Sep 2020
- Primary completion20 Nov 2023
- Study completion14 Aug 2024
Why it stopped: The study was terminated after completion of the Exploratory phase due to 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
- Model description
- The study includes two stages: * Exploratory stage - an exploratory examination of patients with an aim to streamline the study procedures, to reach a safe and consistent result, to evaluate the target patient population and adapt scoring protocol to optimize efficacy of the Leaflex™ procedure. The protocol does not include a formal staticstical analysis of the results of subjects enrolled in this stage. * Confirmatory - confirmatory analysis with an aim to demonstrate the Leaflex™ safety and performance.
- Masking
- None (open label)
- Enrolment
- 33 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
- NCT04649099
- Sponsor's protocol ID
- P02-CLN-019
- Status last verified
- Feb 2025
- First submitted
- 24 Nov 2020
- Last updated
- 28 Feb 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 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Leaflex™ Standalone Study Protocol
- ClinicalTrials.gov ID
- NCT04649099
- Acronym / sponsor ID
- P02-CLN-019
- Conditions
- Aortic Valve Stenosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated after completion of the Exploratory phase due to reprioritization of attention and resources by Sponsor.
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Pi-cardiaIndustry (pharma, biotech, devices)
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 14 Aug 2024 (actual)
- First posted
- 2 Dec 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 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
- Model description
- The study includes two stages: * Exploratory stage - an exploratory examination of patients with an aim to streamline the study procedures, to reach a safe and consistent result, to evaluate the target patient population and adapt scoring protocol to optimize efficacy of the Leaflex™ procedure. The protocol does not include a formal staticstical analysis of the results of subjects enrolled in this stage. * Confirmatory - confirmatory analysis with an aim to demonstrate the Leaflex™ safety and performance.
| 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 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)
- 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.
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
8 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 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 days, 3, 6, 9 and 12 months
Change in pressure gradients
Time frame: 30 days, 3, 6, 9 and 12 months
Results and safety
The study was stopped early (reason given: The study was terminated after completion of the Exploratory phase due to 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 28 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hungary.
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 28 Feb 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 Hungary. 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: The study was terminated after completion of the Exploratory phase due to 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 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 28 Feb 2025.