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.
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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
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Jul 2024
- Lead sponsor
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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
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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 Hide 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
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Herz-und Diabeteszentrum NRW Ruhr-Universität Bochum Bad Oeynhausen
Bad Oeynhausen, 32545, Germany
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University Hospital Mainz
Mainz, 55131, Germany
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University Hospital of Cologne Heart Center
Cologne, 50937, Germany
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Other studies related to the condition(s) this trial covers.
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- Can a single stitch beat a double closure for TAVI patients?
- Can a fitness app boost recovery after heart valve replacement?
- Heart valve fix without the hospital stay? trial tests Same-Day discharge