AzTrials
AzTrials

Aortic Valve DiseasePILATUSNCT06119607

PILot Aortic Triflo Valve Study

A study testing TRIFLO Heart Valve in people with Aortic Valve Disease, run by Novostia SA at 1 site in Lithuania.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

A prospective, single arm, exploratory clinical investigation to assess preliminary safety and collect performance and effectiveness data of the TRIFLO Heart Valve. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Aortic Valve Disease
What is being tested?
TRIFLO Heart Valve
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteLithuania
Study dates
30 Nov 2023to Jun 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient is between 18 and 75 years old.
  • Patient with symptomatic aortic valve disease (stenosis and/or regurgitation) where aortic valve replacement with a mechanical valve is recommended according to the decision of the site heart team and validated by the independent clinical review committee.
  • Patient with a low surgical mortality risk with EuroSCORE II < 4%.
  • Patient with echocardiographic Left Ventricular Ejection Fraction (LVEF) > 35% using Transthoracic Echocardiogram (TTE).
  • Assessment using echocardiography imaging modality of annular suitable for a valve of 21 mm in size and acceptable for the Body Surface Area (BSA) of the patient to avoid any patient prosthesis mismatch.
  • Participants are able to take low-dose aspirin at a dose of 75 -100 mg daily or have a documented contraindication to aspirin use.
Show all 9Show fewer
  • Patient is geographically stable and willing to return to implanting site for follow-up visits up to 5 years.
  • Patient has been adequately informed of risks and requirements of the clinical investigation and is willing and able to provide informed consent for participation.
  • In opinion of the Investigator, the patient has a life expectancy of at least 5 years.

Who cannot join

  • Patient has a pre-existing prosthetic valve (including TAVI) or annuloplasty device or requires replacement or repair of the mitral, pulmonary or tricuspid valve.
  • Patient is maintained on any permanent or long-term anticoagulant therapy (i.e. any A-fib, deep vein thrombosis, lung embolism, percutaneous coronary intervention (PCI), previous ST-elevation myocardial infarct (STEMI)).
  • Patient has a history of vascular-related neurological events (TIA, stroke, intracranial bleeding) occurring within 6 months prior to enrollment.
  • Patient has active endocarditis/myocarditis or other systemic infection within 3 months of the scheduled surgery.
  • Patient has an additional cardiovascular pathology which would increase surgical risk of morbidity or mortality.
  • Patient is planning another unrelated surgical procedure outside of the cardiac area within the next 12 months of study device implantation.
Show all 14Show fewer
  • Patient has renal insufficiency as determined by creatinine (S-Cr) level as ≥ 1.5 mg/dL or end stage renal disease requiring chronic dialysis at screening visit.
  • Patient presents hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to planned valve surgery.
  • Patient has active, clinically relevant bleeding disorder (documented leukopenia (WBC < 4.0 x 103/μL), acute anemia (Hgb < 10.0 g/dL or 6 mmol/L), thrombocytopenia (platelet count < 100 x 103/μL) or history of bleeding diathesis or coagulopathy).
  • Patient has had prior organ transplant or is currently an organ transplant candidate.
  • Patient is currently participating or participated in the last 30 days in another investigational device or drug trial.
  • Patient who is pregnant, plan to become pregnant during the time of the clinical trial or is lactating or patient of childbearing age not taking any effective method of birth control.
  • Patient is considered part of vulnerable population (i.e. prison inmates).
  • Patient with documented history of substance (drug or alcohol) abuse within the last 5 years prior to implantation procedure.

Trial locations and contacts

1 site in 1 country.

Lithuania1 site

  • Vilnius University Hospital Santaros Klinikos

    Vilnius, Vilnius County, LT-08661

Other trials in Lithuania

About this study

Official title: A Prospective, Single-arm, Exploratory Clinical Investigation to Assess Preliminary Safety and Collect Performance and Effectiveness Data of the TRIFLO Heart Valve

A prospective, single arm, exploratory clinical investigation to assess preliminary safety and collect performance and effectiveness data of the TRIFLO Heart Valve.

Read the detailed description

Up to 10 Subjects requiring aortic valve replacement of the native valve will be included in this First in Human clinical investigation on the TRIFLO Heart Valve device in Europe. The study is prospective, single-arm-open-label-non-randomized.

Being tested
TRIFLO Heart Valve
Medical subject headings
Aortic Valve Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TRIFLO Heart ValveDevice

    Surgical Aortic Valve Replacement - Mechanical Valve

Study groups in NCT06119607
Study groupRoleWhat they receive
TRIFLOExperimentalNot described
Receives: Device: TRIFLO Heart Valve

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety - Mortality

    Rate of occurrence of all-cause mortality, cardiovascular, non-cardiovascular, and device-related mortality

    Measured: At 12 and 18 months post procedure

  2. Safety - Thrombotic events

    Rate of valve related thrombotic events

    Measured: Between 3 to 18 months post procedure

Secondary outcomes (21)

  1. Safety - Major adverse cardiovascular events

    Rate of occurrence of MACEs

    Measured: 1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months

  2. Safety - Thromboembolism events

    Rate of occurrence of Transient Ischemic Attack (TIA), coronary and/or peripheral embolism

    Measured: 1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months.

  3. Safety - Thrombotic events

    Rate of valve-related thrombotic events

    Measured: 24, 36, 48 and 60 months.

  4. Safety - Atrial Fibrillation

    Rate of occurrence of New Onset Atrial Fibrillation

    Measured: 3, 9, 12, 15, 18, 24, 36, 48 and 60 months

  5. Safety - Endocarditis

    Rate of occurrence of Endocarditis

    Measured: 1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months.

  6. Safety - Hemolysis

    Rate of occurrence of Hemolysis followed by Plasma free hemoglobin

    Measured: 1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months.

  7. Safety - Reoperation

    Rate of occurrence of Reoperation

    Measured: 1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months.

  8. Safety - Structural & Non structural Valve Dysfunction

    Rate of occurrence of Structural \& Non structural Valve Dysfunction

    Measured: 1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months.

  9. Safety - Bleeding

    Rate of occurrence of bleeding classified according to BARC

    Measured: 1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months.

  10. Safety - Pacemaker

    Rate of occurrence New pacemaker implantation due to intervention

    Measured: 3 months

  11. Safety - All-cause mortality

    Rate of occurrence of All-cause mortality, cardiovascular, non-cardiovascular, and device related mortality

    Measured: 1, 3, 9, 15, 24, 36, 48 and 60 months

  12. Safety - Procedural mortality

    Rate of occurrence of Procedural mortality

    Measured: 1 month.

  13. Performance - Procedure

    Rate of initial success, correct positioning of a single TRIFLO Heart Valve into the proper anatomical location.

    Measured: Procedure

  14. Performance - Hemodynamics

    Change of hemodynamics compared to baseline followed by mean aortic valve pressure gradient

    Measured: 1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months

  15. Performance - Regurgitation

    Change of regurgitation class (As per VARC 3 Classification Guidelines) compared to baseline

    Measured: 1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months

  16. Performance - EOA

    Change of Effective Orifice Area (EOA) compared to baseline

    Measured: 1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months

  17. Performance - Noise

    Assessment of noise perception - patient survey

    Measured: 3, 9, 12, 15, 18, 24, 36, 48 and 60 months

  18. Effectiveness - NYHA

    Change of NYHA Score compared to baseline

    Measured: 1, 3, 9, 12, 18, 24, 36, 48 and 60 months

  19. Effectiveness - QoL

    Change of Quality-of-life Score using KCCQ-12 questionnaires, compared to baseline

    Measured: 1, 3, 9, 12, 18, 24, 36, 48 and 60 months

  20. Effectiveness - 6MWT

    Functional Assessment in 6-min walk test

    Measured: 3, 9, 12, 18, 24, 36, 48 and 60 months

  21. Usability

    Assessment of device handling ease by the physician - survey

    Measured: Procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2023
  2. Study start30 Nov 2023
  3. Primary completionDec 2025 (estimated)
  4. Study completionJun 2029 (estimated)

Resources

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
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06119607
Sponsor's protocol ID
100144
Other IDs
CIV-LT-23-08-043783
Acronym
PILATUS
Status last verified
Jun 2025
First submitted
31 Oct 2023
Last updated
15 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing TRIFLO Heart Valve in people with Aortic Valve Disease, run by Novostia SA at 1 site in Lithuania.

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 9 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 15 Aug 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 Lithuania. 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?

This study is still under way. Results are not available in the source record yet.

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?

Safety - Mortality (time frame: At 12 and 18 months post procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06119607.

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 15 Aug 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in