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New Dual-Action heart procedure could tame stubborn AFib

NCT ID NCT06165510

Disease control Sponsor: Barts & The London NHS Trust 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new two-step procedure for people with long-standing persistent atrial fibrillation (AFib), a type of irregular heartbeat. The procedure combines a minimally invasive surgery on the outside of the heart with a standard catheter ablation inside the heart. Researchers want to see if this approach is safe and works better than standard ablation alone. The trial will enroll 48 adults with persistent AFib for over a year and follow them for 12 months.

What this could mean

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

Active substance
Convergent ablation procedure using AtriCure EPi-Sense-AF system and LARIAT device
What this could lead to
If successful, this could offer a more effective treatment option for people with long-standing persistent atrial fibrillation, potentially reducing the need for repeat procedures.
What could go wrong
This is a small early feasibility trial with only 48 participants, so results may not apply to everyone. The procedure is more invasive than standard ablation and carries risks like bleeding, infection, or heart complications.

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 48 people

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

Started

Aug 2024

Expected to finish

Nov 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 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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; \< 80 years * Persistent AF \> 1-year duration * Left atrium size \< 6cm * Pts should be able to provide written informed consent. Exclusion Criteria: * Subjects currently enrolled in another investigational study except in case of observational registry with no associated treatments. * Subject has a reversible cause of AF or transient AF * Subject is absent of LAA or if the LAA is previously surgically ligated * Subject has had previous cardiac surgery or abdominal surgery. * Subject has contraindication to anticoagulation. * Patients with hypertrophic cardiomyopathy. * Patients with significant valve disease. * Subject has had previous catheter or surgical ablation

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Conditions

The condition(s) this trial relates to.

Arrhythmias, Cardiac atrial fibrillation persistent atrial fibrillation

As listed by the trial registrant

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

Atrial arrhythmia Atrial fibrillation, persistent Atrium; fibrillation Persistent atrial fibrillation

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

    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

    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

  • St Bartholomew's Hospital

    RECRUITING

    London, EC1A 4AS, United Kingdom

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