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Stitch or device? study tests best way to seal vein after pacemaker implant

NCT ID NCT06837870

Knowledge-focused Sponsor: University of Massachusetts, Worcester 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two methods to close the large vein used for implanting a leadless pacemaker: a special closure device versus a figure-of-eight stitch with manual pressure. Researchers will measure how quickly bleeding stops and how soon patients can go home. The goal is to find which approach is safer and more effective for 50 adults undergoing this procedure.

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 works better, it could make recovery faster and safer for people getting leadless pacemakers.
What could go wrong
This is a small, early study with only 50 people, so results may not apply to everyone. Both methods have known risks like bleeding or bruising.

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 50 people

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

Started

Jul 2025

Expected to finish

Jan 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: * Patients aged 18 and older * Patients undergoing leadless pacemaker implant at UMass Chan Medical Center * Subjects able to understand and provide written informed consent. Exclusion Criteria: * Patients who are pregnant * Patents who are not able to ambulate prior to the procedure * Other conditions that, in the opinion of the investigator constitute a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct or evaluation * Prisoners or wards of the state.

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Conditions

The condition(s) this trial relates to.

vascular occlusion disorder

As listed by the trial registrant

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

Leadless pacemaker Pacemaker implantation Vascular closure

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • UMass Chan Medical School

    Worcester, Massachusetts, 01655, United States

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