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Suture device may get heart patients walking sooner after leg vein procedures

NCT ID NCT07827287

Symptom relief Sponsor: Ewha Womans University Mokdong Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Last updated Sep 18, 2026

Summary

Researchers are testing whether a suture-based closure device helps patients recover faster after heart procedures that use a large tube placed in the femoral vein. The trial enrolls adults undergoing procedures such as atrial fibrillation ablation, leadless pacemaker insertion, or atrial septal defect closure. Participants are randomly assigned to have the puncture site closed with the Perclose ProStyle device or with standard manual compression or a figure-of-eight stitch. The main measure is how long it takes to walk again after the tube is removed, with other measures including time to stop bleeding, time until discharge is possible, patient satisfaction, and vascular complications within 30 days.

What this could mean

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

Active substance
Perclose ProStyle Suture-Mediated Closure System, a device that seals the puncture site in the femoral vein after heart procedures
What this could lead to
If the device works, patients could walk sooner after heart procedures done through the leg vein and may have fewer bleeding problems at the access site.
What could go wrong
The device may not speed up walking compared with standard compression, and it carries small risks of bleeding, infection, or device failure. The trial is not blinded, so expectations could affect some measurements.

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 200 people

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

Started

Feb 2026

Expected to finish

Dec 2028

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

19 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: * Patients aged 19 years or older undergoing cardiologic procedures via femoral vein access * Patients who provide written informed consent to participate in the study Exclusion Criteria: * Patients with active systemic infection or local infection at the vascular access site * Patients with known severe allergy to contrast media or device components * Patients unable to provide informed consent

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Conditions

The condition(s) this trial relates to.

atrial fibrillation atrial septal defect

As listed by the trial registrant

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

Atrial fibrillation Atrial septal defect Vascular closure device

How to take part

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

  • Ewha Womans University Mokdong Hospital

    Seoul, South Korea

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