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Heart valve replacement safe in patients with enlarged aorta?

NCT ID NCT07148973

Knowledge-focused Sponsor: zjq 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed study looked at 101 patients with severe aortic stenosis who had a minimally invasive heart valve replacement (TAVR). Researchers wanted to see if the procedure was safe for patients who also had an enlarged ascending aorta (≥40 mm). They compared outcomes like death rates between those with and without an enlarged aorta. The goal was to gather information to help guide future treatment decisions for this specific group.

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 Replacement (TAVR) procedure
What this could lead to
If successful, this study could help doctors better understand whether TAVR is safe for patients with an enlarged aorta, potentially expanding treatment options for this group.
What could go wrong
This is a small, single-center study with only 101 participants, so results may not apply to all patients. It is observational, so it cannot prove cause and effect.

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

101 people

The number who actually took part.

Started

Jan 2019

Finished

Jul 2021

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.

Who is studied

All patients who were diagnosed with severe AS via the TAVR procedure using a self-expanding valve (Venus-A valve, Qiming Med Tech Inc., Hangzhou, China) between January 2019 and July 2021 at our Heart Center were retrospectively enrolled.

Ages

50 to 93 years

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) severe AS patients diagnosed on the recommendation of the European Society of Cardiology/European Association for Cardio-Thoracic Surgery Guidelines (aortic valve area ≤ 1.0 cm²/aortic valve index ≤ 0.6 cm²/m²/peak aortic velocity (Vmax)≥4.0 m/s); (2) patients at intermediate- to high-risk surgical risk or a Society of Thoracic Surgeons risk (STS) score \> 4; (4) patients whose anatomy was evaluated by 3-dimensional (3D) multidetector computed tomography (MDCT) appropriate for TAVR; and (4) patients with severe AS with typical symptoms. Exclusion Criteria: * (1) patients with active endocarditis, acute aortic dissection, or acute myocardial infarction; (2) patients with expectations of life\< 1 year; and (3) patients with inappropriate anatomy evaluated by 3D MDCT.

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Conditions

The condition(s) this trial relates to.

aneurysm or dilatation of ascending aorta Aneurysm, Ascending Aorta aortic valve stenosis

As listed by the trial registrant

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

Ascending aortic dilation Transcatheter aortic valve replacement (TAVR)

Contacts and locations

Locations

  • the Affiliated Zhongshan Hospital of Dalian University

    Dalian, Liaoning, 116001, China

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