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New heart valve device shows promise for High-Risk patients

NCT ID NCT03613246

Disease control Sponsor: NVT GmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how well the ALLEGRA TAVI system works in real-world patients with severe aortic valve disease who are at high risk for surgery. Researchers tracked 346 patients to see if the device improves survival and quality of life. The goal is to control the disease and reduce symptoms, not to cure it.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

346 people

The number who actually took part.

Started

Feb 2019

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Symptomatic patients with elevated surgical risk and candidate for TAVI with severe calcified and stenotic aortic valves or failing surgical bioprosthetic aortic valves.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Symptomatic degeneration of severe calcified aortic heart valve OR failing surgical aortic bioprosthetic valve 2. Acceptable candidate for elective treatment with the ALLEGRA TAVI System TF (according to the most recent version of the ALLEGRA Instructions For Use) 3. High risk for surgery as assessed by the heart team 4. Has signed the Patient Informed Consent Form \>= 18 years Exclusion Criteria: General: 1. Echocardiographic evidence of intracardiac thrombus or vegetation 2. Significant aortic disease such as severe obstructive calcification or marked tortuosity or kinking which will preclude a safe advancement of the ALLEGRA TAVI System TF 3. Iliofemoral vessel conditions such as severe obstructive calcification, severe tortuosity or kinking that would preclude safe placement of an 18 Fr introducer sheath or make endovascular access to the aortic valve impossible 4. Severe ventricular dysfunction with LVEF \<20% 5. Evidence of active endocarditis or other acute infections 6. Renal failure requiring continuous renal replacement therapy 7. 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 8. Life expectancy ≤ 12 months due to other medical illness 9. Currently participating in another investigational drug or device study Patients with native aortic valve disease: 1. Unicuspid or bicuspid aortic valve 2. Non-calcified aortic stenosis 3. Combined aortic valve disease with predominant aortic regurgitation \> 3 4. Distance between aortic valve basal plane and the orifice of the lowest coronary artery \< 8 mm Patients with degenerated surgical bioprosthetic aortic valves: 1. Low position of the coronary ostia, especially in combination with shallow sinuses 2. Internal diameter of the bioprosthesis is ≤16 mm or \>28 mm 3. Partially detached leaflets that in the aortic position may obstruct a coronary ostium

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Transcatheter aortic valve implantation

Contacts and locations

Locations

  • Clinica Mediterranea Neapel

    Naples, Italy

  • Heartcentre Catharina Hospital Eindhoven

    Eindhoven, 5623 EJ, Netherlands

  • Herz- und Gefäßzentrum Bad Bevensen

    Bad Bevensen, 29549, Germany

  • Hospital Alvaro Cunqueiro

    Vigo, 36213, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010, Spain

  • Hospital Universitario de Salamanca

    Salamanca, 37007, Spain

  • Kath. Marienkrankenhaus

    Hamburg, 22087, Germany

  • MH Hannover

    Hanover, 30625, Germany

  • Morriston Hospital

    Swansea, United Kingdom

  • Ospedale San Raffaele

    Milan, 20132, Italy

  • Oulu University Hospital

    Oulu, 90220, Finland

  • SLK-Kliniken Heilbronn

    Heilbronn, 74078, Germany

  • Schuechtermann-klinik

    Bad Rothenfelde, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.