Can a less invasive valve replacement tame a failing aortic valve?

NCT ID NCT05536310

Stopped early, before it reached the end. That can be for many reasons, including safety.

First seen Aug 21, 2026 · Last updated Aug 21, 2026

Summary

This study is a patient registry that collects information on people with severe aortic stenosis or aortic regurgitation who are treated with the Trilogy heart valve system, a device implanted via a catheter (TAVI) to replace the aortic valve without open-heart surgery. The goal is to track outcomes like death, stroke, and bleeding complications in real-world patients who are at high risk for traditional surgery. By gathering this data, researchers hope to better understand how well the device works and its safety in everyday clinical practice.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
Transcatheter aortic valve implantation (TAVI) using the JenaValve Trilogy Heart Valve System
What this could lead to
If successful, this registry could provide evidence supporting the Trilogy system as a safe and effective option for patients with severe aortic valve disease who are not candidates for open-heart surgery.
What could go wrong
This is a small observational registry, not a randomized trial, so it may not prove the device is better than alternatives. Risks of TAVI include bleeding, vascular complications, and stroke.

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

24 people

The number who actually took part.

Started

Aug 2023

Finished

Jul 2024

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

Patients with symptomatic severe aortic regurgitation or symptomatic severe aortic stenosis undergoing treatment with JenaValve Trilogy Heart Valve System

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. Patients who have signed ICF and are indicated by their doctors to be treated with Trilogy Heart Valve System in line with the medical standard of care 2. Patients with symptomatic severe aortic regurgitation (AR) or symptomatic, severe aortic stenosis (AS), who are at high risk for SAVR as documented by the heart team and Heart Team agrees that patient can undergo SAVR for "bail out"/to address unfavorable circumstances if necessary 3. Patients 18 years of age or older 4. Patient is willing to participate in the study, provides signed Informed Consent/Data Authorization Form and authorizes the sharing of data in the study 5. The subject and treating physician agree the subject will return for all required post-procedure follow-up visits Exclusion Criteria: 1. Patients who have known hypersensitivity or contraindication to Nitinol (titanium and/or nickel), an anti-coagulation/anti-platelet regimen or contrast medium that cannot be managed with premedication 2. Patients who have active bacterial endocarditis or other active infections 3. Pediatric (\<18 years) and/or pregnant/nursing patients 4. Congenital/functional unicuspid, bicuspid or quadricuspid native aortic valve morphology 5. Previous prosthetic aortic valve (bioprosthesis or mechanical) implant 6. Echocardiographic evidence of current left heart thrombus 7. Hypertrophic cardiomyopathy with or without obstruction. 8. Access vessel characteristics that would preclude safe placement of the JenaValve 20Fr introducer sheath, such as severe obstructive calcification, severe tortuosity, or vessel diameter \<7mm.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Herz-und Diabeteszentrum NRW Ruhr-Universität Bochum Bad Oeynhausen

    Bad Oeynhausen, 32545, Germany

  • University Hospital Mainz

    Mainz, 55131, Germany

  • University Hospital of Cologne Heart Center

    Cologne, 50937, Germany

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