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New registry tracks safety of Artery-Closing device in heart procedures

NCT ID NCT05936996

Knowledge-focused Sponsor: Essential Medical, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 watched 258 people getting a new heart valve (TAVR) to see how a device called MANTA closes the large hole in the leg artery. The goal was to check for bleeding problems and how fast the artery seals. No new treatments were tested; researchers just collected real-world safety data.

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

258 people

The number who actually took part.

Started

Nov 2023

Finished

Oct 2025

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

Qualifying subjects undergoing TAVR using the MANTA® VCD for large bore closure.

Ages

21 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: * Candidate meets criteria for on-label use of MANTA® VCD as specified in the country-specific MANTA® VCD Instructions for Use (IFU), per judgement of the investigator. * Age ≥21 years Exclusion Criteria: * Unable or unwilling to give informed consent or unwilling to complete follow-up assessments.

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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.

Femoral arteriotomy closure

Contacts and locations

Locations

  • Baptist Health Medical Center-Jacksonville

    Jacksonville, Florida, 32207, United States

  • Baylor Scott & White - Round Rock

    Round Rock, Texas, 78665, United States

  • Henry Ford Health

    Detroit, Michigan, 48202, United States

  • Montefiore Medical Center

    New York, New York, 10467, United States

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8, Canada

  • Mount Sinai Hospital

    New York, New York, 10029, United States

  • North Shore University Hospital

    Manhasset, New York, 11030, United States

  • Orlando Health, Inc

    Orlando, Florida, 32806, United States

  • University at Buffalo

    Buffalo, New York, 14203, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

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