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Transcatheter Aortic Valve ImplantationEMPIRENCT05478161

Investigation of the ALLEGRA THV System With a New Delivery System in Patients With Aortic Stenosis or Failed Surgical Bioprosthesis

A study testing (ALLEGRA Transcatheter Heart Valve) TAVI in severe calcified aortic stenosis or in failed surgical aortic bioprosthesis in people with Transcatheter Aortic Valve Implantation, run by NVT GmbH at 11 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The EMPIRE study confirms the technical performance of the new IMPERIA Delivery System and evaluates the safety and efficacy of the entire ALLEGRA THV System. The primary endpoint is device success rate at 7 days (discharge from index procedure or 7 days post implant, whichever comes first), as defined by VARC 2. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Transcatheter Aortic Valve Implantation
What is being tested?
(ALLEGRA Transcatheter Heart Valve) TAVI in severe calcified aortic stenosis or in failed surgical aortic bioprosthesis
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
137 participants
Where
11 sitesin 3 countries
Study dates
24 Jan 2023to 17 Dec 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

  • Symptomatic severe calcific stenosis of a native aortic valve with an AVA ≤1.0 cm2 (or AVA index ≤0.6 cm2/m2), AND mean aortic pressure gradient ≥ 40mmHg OR maximal transaortic velocity ≥4.0m/s OR Doppler velocity index ≤0.25 on site-reported echocardiography OR symptomatic patients with degeneration of a surgical bioprosthetic valve (stenosis +/- insufficiency) on site-reported echocardiography
  • Local multi-disciplinary Heart Team and Central Screening Committee (CSC) agree on indication and eligibility for TAVI
  • Age ≥18 years
  • Patient has signed the Patient Informed Consent Form
  • Patient is willing and able to comply with requirements of the study, including all follow-up visits

Who cannot join

  • General:
  • Mean aortic annulus diameter as measured by pre-procedural CT or internal diameter of the bioprosthesis is <16.5 mm or >27 mm
  • Echocardiographic evidence of intracardiac thrombus or vegetation (site-reported)
  • Significant disease of the aorta that would preclude safe advancement of the ALLEGRA THV System
  • Severe ilio-femoral vessel disease that would preclude safe placement of an 18 Fr introducer sheath or make endovascular access impossible
  • Porcelain aorta
Show all 31Show fewer
  • Severe left ventricular dysfunction with ejection fraction (EF) <20% (site-reported)
  • Evidence of active endocarditis or other acute infections
  • Renal failure requiring continuous renal replacement therapy
  • Untreated clinically significant coronary artery disease requiring revascularization
  • Any percutaneous interventional procedure (e.g. PCI with stenting) within 14 days prior of the index procedure
  • Acute MI ≤30 days prior to the index procedure
  • Symptomatic carotid or vertebral artery disease requiring intervention or carotid/vertebral intervention within the preceding 45 days
  • Cerebrovascular accident (CVA) or transient ischemic attack (TIA) ≤6 months or prior CVA with moderate or severe disability (e.g. modified Rankin scale score >2)
  • History of bleeding diathesis or coagulopathy; acute blood dyscrasias as defined: thrombocytopenia (platelets <80,000/µl), acute anemia (hemoglobin <10 g/dl), leukopenia (WBC <3000/ µl)
  • Active peptic ulcer or gastrointestinal (GI) bleeding ≤3 months
  • Severe (greater than 3+) mitral insufficiency (site-reported)
  • Uncontrolled atrial fibrillation
  • Required emergency surgery for any reason
  • Known hypersensitivity to contrast media, which cannot be adequately pre-medicated or contraindication to anticoagulant or anti-platelet medication or to nitinol alloy or to bovine tissue
  • Life expectancy ≤12 months due to other medical illness
  • Currently participating in another investigational drug or device study
  • Pregnancy or intend to become pregnant during study participation
  • Specific exclusions in patients with native aortic valve disease (site-reported):
  • Unicuspid or bicuspid aortic valve
  • Non-calcified aortic stenosis
  • Predominant aortic regurgitation > grade 3
  • Distance between native aortic valve basal plane and the orifice of the lowest coronary artery <8 mm
  • Specific exclusions in patients with degenerated surgical bioprosthetic aortic valves (valve-in-valve) (site-reported):
  • Low position of the coronary ostia, especially in combination with shallow sinuses (high risk of coronary occlusion)
  • Partially detached leaflets that may obstruct a coronary ostium

Trial locations and contacts

11 sites in 3 countries.

11 sites in 3 countries

Spain5 sites

  • Hospital Universitari de Bellvitge

    Barcelona

  • Hospital Clínico San Carlos

    Madrid

  • Hospital Universitario Virgen de la Victoria

    Málaga

  • Hospital Universitario de Salamanca

    Salamanca

  • Hospital Alvaro Cunqueiro

    Vigo, 36213

Other trials in Spain

Germany3 sites

  • Herz- und Gefäßzentrum Bad Bevensen

    Bad Bevensen

  • Schüchtermann Klinik

    Bad Rothenfelde, Lower Saxony, 49214

  • UKSH, Campus Lübeck

    Lübeck

Other trials in Germany

Netherlands3 sites

  • Catharina Hospital

    Eindhoven

  • Maastricht University Medical Center

    Maastricht

  • Erasmus Medical Center

    Rotterdam

Other trials in Netherlands

About this study

Official title: Investigation of the Safety and Performance of the NVT ALLEGRA THV System With a New Delivery System in Patients With Severe Calcified Aortic Stenosis or Failed Surgical Aortic Bioprosthesis

The EMPIRE study confirms the technical performance of the new IMPERIA Delivery System and evaluates the safety and efficacy of the entire ALLEGRA THV System.

The primary endpoint is device success rate at 7 days (discharge from index procedure or 7 days post implant, whichever comes first), as defined by VARC 2.

Based on the outcomes of a study with a similar device and considering a drop-out rate of 5%, 107 patients need to be enrolled in the study.

Being tested
(ALLEGRA Transcatheter Heart Valve) TAVI in severe calcified aortic stenosis or in failed surgical aortic bioprosthesis
Keywords
TAVI, Aortic valve stenosis, ALLEGRA, IMPERIA
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.

  • (ALLEGRA Transcatheter Heart Valve) TAVI in severe calcified aortic stenosis or in failed surgical aortic bioprosthesisDevice

    Implantation of the ALLEGRA Transcatheter Heart Valve in failing surgical bioprosthesis

Study groups in NCT05478161
Study groupRoleWhat they receive
treatmentExperimentalTAVI in severe calcified aortic stenosis or in failed surgical aortic bioprosthesis
Receives: Device: (ALLEGRA Transcatheter Heart Valve) TAVI in severe calcified aortic stenosis or in failed surgical aortic bioprosthesis

What is being measured

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

  1. Device success at 7 days

    • Absence of procedural mortality AND
    • Correct positioning of a single device in the proper anatomical location (site-reported) AND
    • Intended performance of the prosthetic heart valve (as determined by an independent Echo Core Lab at discharge from index procedure or 7 days post implant, whichever comes first)
    • Indexed Effective Orifice Area (iEOA) > 0.85 cm2/m2 for BMI < 30kg/m2 and iEOA > 0.70 cm2/m2 for BMI ≥ 30kg/m2
    • Mean aortic valve gradient <20 mmHg or peak velocity <3 m/s
    • No moderate or severe prosthetic valve regurgitation

    Measured: 7 day

Secondary outcomes (14)

  1. All-cause mortality

    Measured: up to 12 months

  2. Cardiovascular mortality

    Measured: up to 12 months

  3. All stroke

    Measured: up to 12 months

  4. TIA

    Measured: up to 12 months

  5. Procedural success

    • Successful vascular access, delivery and deployment of the ALLEGRA THV including re- positioning if required and successful retrieval of the IMPERIA Delivery System (site- reported)
    • Correct position of the ALLEGRA THV (site-reported)
    • Only one ALLEGRA THV implanted in proper anatomical position (site-reported)

    Measured: assessed immediately after the procedure

  6. Effective orifice area (EOA) as assessed by transthoracic echocardiogram (TTE)

    Measured: up to 12 months

  7. Transvalvular mean and peak pressure gradient as assessed by transthoracic echocardiogram (TTE)

    Measured: up to 12 months

  8. Trans- and paravalvular regurgitation as assessed by transthoracic echocardiogram (TTE)

    Measured: up to 12 months

  9. NYHA classification

    Measured: 30 days, 6 months, and 12 months

  10. Early safety

    • All-cause mortality
    • All stroke (disabling and non-disabling)
    • Life-threatening bleeding
    • Acute kidney injury-Stage 2 or 3 (including renal replacement therapy)
    • Coronary artery obstruction requiring intervention
    • Major vascular complication
    • Valve-related dysfunction requiring repeat procedure (BAV, TAVI, or SAVR)

    Measured: up to 30 days

  11. Time-related valve safety

    • Structural valve deterioration
    • Valve-related dysfunction (mean aortic valve gradient
    • 20 mmHg, EOA ≤0.9-1.1 cm2c and/or DVI <0.35 m/s, AND/OR moderate or severe prosthetic valve regurgitation)
    • Requiring repeat procedure (TAVI or SAVR)
    • Prosthetic valve endocarditis
    • Prosthetic valve thrombosis
    • Thrombo-embolic events (e.g. stroke)
    • VARC bleeding, unless clearly unrelated to valve therapy (e.g. trauma)

    Measured: up to 12 months

  12. Quality of life as assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)

    Assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ-12). Patients are asked questions about physical limitation, symptom frequency, quality of life, and social limitation. Responses are given on a Likert scale that for each individual item is scored on a scale of 0-100 with higher scores indicating better health.

    Measured: up to 12 months

  13. New pacemaker implantation

    Measured: up to 12 months

  14. Delivery system related AEs

    Measured: discharge from index procedure or 7 days post implant, whichever comes first

Timeline

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

  1. First posted28 Jul 2022
  2. Study start24 Jan 2023
  3. Primary completion20 Dec 2023
  4. Study completion17 Dec 2024

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
137 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05478161
Sponsor's protocol ID
NVT05EMP
Acronym
EMPIRE
Status last verified
Feb 2026
First submitted
19 Jul 2022
Last updated
24 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing (ALLEGRA Transcatheter Heart Valve) TAVI in severe calcified aortic stenosis or in failed surgical aortic bioprosthesis in people with Transcatheter Aortic Valve Implantation, run by NVT GmbH at 11 sites in 3 countries.

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 5 inclusion and 31 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: finished, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Spain, Germany, Netherlands. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Device success at 7 days (time frame: 7 day). 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 NCT05478161.

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 24 Feb 2026.

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