Cure My Disease

Don't miss your cure!

 Log in / Sign up

Which heart valve design wins for small aortic openings?

NCT ID NCT07794306

Disease control Sponsor: Universitätsklinikum Hamburg-Eppendorf 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This trial compares two types of replacement heart valves used in a procedure called TAVI for people with severe aortic valve stenosis and a small aortic annulus. The two valves are the Meril Octapro+ and the Abbott Navitor. Researchers want to see which design provides better safety and heart function after the procedure, and which may be easier to replace in the future if the valve wears out. The study enrolls adults who are suitable for both valve types.

What this could mean

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

Active substance
Two types of transcatheter aortic valve replacement (TAVI) devices: the Meril Octapro+ THV System and the Abbott Navitor/Navitor Vision THV system
What this could lead to
If this trial succeeds, it could identify which TAVI valve design works best for people with small aortic annuli, improving heart function and reducing complications, and potentially making future valve-in-valve procedures easier.
What could go wrong
This is a randomized trial, but the results may not apply to all patients. There are risks of bleeding, stroke, or needing a pacemaker after the procedure. The trial does not yet have long-term data on valve durability.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 510 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2033

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

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: * Participants 18 years of age or older * Heart team consensus that isolated transfemoral TAVI is medically justified and advisable * Diagnosis of severe symptomatic aortic valve stenosis and aortic annulus ≤ 430 mm² as seen in preoperative CT diagnostic * Anatomy is suitable for both BE and SE THVs according to Heart Team judgement * Participant provided written informed consent to participate in the trial * Ability of participant to understand patient information and to personally sign and date informed consent to participate in trial, before performing any trial-related procedures * Participant and treating physician agree that participant will return for all required postprocedural follow-up visits Exclusion Criteria: * Uni- or bicuspid aortic valve pathology * Severe Left ventricular outflow tract (LVOT) calcification with prohibitive risk for BE THV as determined by heart team * Non-calcified aortic valve pathology or endocarditis * Expected life expectancy \<12 months due to associated non-cardiac comorbidities * Currently participating in another investigational drug or device trial * Urgent or emergency TAVI

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Aortic valve stenosis are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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.

Aortic valve stenosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University Medical Center Hamburg-Eppendorf (UKE), University Heart and Vascular Center Hamburg

    Hamburg, Free and Hanseatic City of Hamburg, 20249, Germany

More trials for these conditions

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