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New device may simplify ECMO removal, reduce bleeding risks

NCT ID NCT07019662

Disease control Sponsor: IHF GmbH - Institut für Herzinfarktforschung Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a special suture device (Perclose ProStyle) can close the artery as safely as standard methods (manual pressure or surgery) after removing ECMO tubes in patients with severe heart and lung failure. About 102 adults on VA-ECMO will be randomly assigned to the device or standard care. The goal is to see if the device reduces complications like bleeding, blood clots, or vessel injury.

What this could mean

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

Active substance
Abbott Perclose™ ProStyle™ Suture-Mediated Closure System
What this could lead to
If successful, this could provide a less invasive, safer way to close arteries after ECMO removal, reducing bleeding and recovery time.
What could go wrong
This is a relatively small, early-stage trial (102 participants) comparing a device to varied standard practices, so results may not apply broadly. Device failure could cause bleeding or vessel injury.

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 102 people

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

Started

Oct 2025

Expected to finish

Sep 2027

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: * Age ≥ 18 Years * Femoral placement of VA-ECMO with peripheral, percutaneous cannulation * Arterial puncture site above the femoral bifurcation * Cannula size must match or be smaller than the maximally licensed diameter for Perclose™ ProStyle™ (26 F (French) outer diameter arterial and 29 F outer diameter veinous) * Patients must be eligible for either the Perclose™ ProStyle™ device or one of the two guideline-compliant alternatives for ECMO cannula removal (manual compression or surgical closure) according to the investigator's judgment. * Initial arterial and/or venous puncture for ECMO cannulation was performed using ultrasound guidance with corresponding documentation available in the patient record. Exclusion Criteria: * Severe calcification * Surgical cannulation * Ongoing Infection of the ECMO site * Any patient who does not fullfil the eligibility criteria for the use of the study device according to its current Instructions for Use (IFU), including known contraindications, limitations or warnings. * Participation in another interventional clinical trial. * Patients who are pregnant (assessed by clinical routine testing) or lactating.

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As listed by the trial registrant

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

Va-ecmo

How to take part

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

  1. The places running it

    2 sites. 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

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Contacts and locations

Locations

  • Universitäres Herz- und Gefäßzentrum Frankfurt ZIM - Med. Clinic 3 - Cardiology and Angiology

    RECRUITING

    Frankfurt, Germany

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz - Zentrum für Kardiologie

    RECRUITING

    Mainz, Germany

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