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New disc may get heart patients walking faster after ablation

NCT ID NCT06627959

Symptom relief Sponsor: Mid and South Essex NHS Foundation Trust 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a sticky disc called StatSeal helps people recover faster after a common heart procedure for atrial fibrillation. After the procedure, doctors must close the blood vessel in the leg to stop bleeding. Currently, they often use a stitch (figure-of-eight). This trial will randomly assign 160 patients to get either the disc or the stitch. The main goal is to see if the disc lets patients walk sooner, which could mean a quicker hospital discharge.

What this could mean

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

Active substance
StatSeal device (hemostatic disc) and figure-of-eight suture
What this could lead to
If StatSeal works better, patients may walk sooner after AF ablation, leading to faster discharge and improved comfort.
What could go wrong
This is a small, early-stage study (160 people). StatSeal may not speed recovery or could cause more side effects than the standard suture.

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

160 people

The number who actually took part.

Started

Jan 2025

Expected to finish

Jan 2026

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: * Male and female patients age \>18 * Elective catheter ablation for atrial fibrillation using a 6 to 14 Fr inner diameter introducer sheath with a minimum of 1 and maximum of 3 femoral venous access sites * Willing and able to give informed consent Exclusion Criteria: * Active systemic or cutaneous infection, or inflammation in vicinity of the groin * Platelet count \< 100,000 cells/mm3 * BMI \> 45 kg/m2 or \< 20 kg/m2 * Attempted femoral arterial access or inadvertent arterial puncture * Procedural complications that interfered with routine recovery, ambulation, or discharge times * Incorrect sheath placement * Intraprocedural bleeding or thrombotic complications * Access site-specific eligibility criteria to exclude problems with gaining access or location of sheath * History of bleeding diathesis, coagulopathy, hypercoagulability, or thromboembolic events

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Conditions

The condition(s) this trial relates to.

atrial fibrillation

As listed by the trial registrant

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

Atrial fibrillation (AF) Vascular access

Contacts and locations

Locations

  • East Sussex Healthcare NHS Trust

    Eastbourne, BN21 2UD, United Kingdom

  • Norfolk and Norwich University Hospital

    Norwich, NR4 7UY, United Kingdom

  • The Essex Cardiothoracic Centre

    Basildon, Essex, SS16 5NL, United Kingdom

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