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Which artery closure method is safer after TAVR? new study has answers

NCT ID NCT06983938

Knowledge-focused Sponsor: Baylor Research Institute 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested two different methods of closing the main leg artery after a minimally invasive heart valve replacement (TAVR). One method used two small stitch-like devices, the other used one stitch device plus a plug. The goal was to see which approach caused fewer bleeding or blood vessel problems. The study involved 92 adults and was completed at a single center.

What this could mean

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

What this could lead to
If one method proves safer, it could become the preferred way to close the artery after TAVR, reducing complications.
What could go wrong
This is a small, single-center study with only 92 participants, so results may not apply to all hospitals or patients. It compares two existing techniques, not a new breakthrough.

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

92 people

The number who actually took part.

Started

Feb 2025

Finished

Oct 2025

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: * Age ≥ 18 years old * Planned to undergo transcatheter aortic valve replacement via femoral access * Able to provide written informed consent prior to study participation Exclusion Criteria: * Non-femoral access * Previous repair or intervention of the common femoral artery * Previous pseudoaneurysm of the common femoral artery * Children below 18 years, prisoners, and patients who are unable to provide consent are excluded. * In another research study that has not granted permission to dual-enroll.

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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.

Closure technique Transcatheter aortic valve replacement

Contacts and locations

Locations

  • Baylor Scott & White The Heart Hospital - Plano

    Plano, Texas, 75093, United States

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