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Heart surgery upgrade: new device combo aims to stop AFib before it starts

NCT ID NCT06989775

Prevention Sponsor: AtriCure, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 30, 2026 · Updated 3 times

Summary

This study tests whether using a special clamp (EnCompass) to create a scar line in the heart and a clip (AtriClip) to close off a small pouch can prevent new atrial fibrillation after heart surgery. The trial will enroll 960 people aged 65 or older who are having planned heart surgery but have never had AFib. Half will get the standard surgery alone, and half will get the standard surgery plus the clamp and clip procedure.

What this could mean

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

Active substance
Isolator Synergy EnCompass Ablation System and AtriClip LAA Exclusion System
What this could lead to
If it works, this could become a standard preventive step during heart surgery to stop atrial fibrillation from ever starting.
What could go wrong
This is a large trial, but the procedure adds time and risk to surgery. It may not reduce AF enough to justify the extra steps, and long-term benefits are still unknown.
Why investors are watching

AtriCure makes the EnCompass clamp and AtriClip devices that this trial tests. The study asks whether using them to block the left atrial appendage and create a box lesion during routine heart surgery prevents a common complication, post operative atrial fibrillation, in patients who have not had AF before. For a small company, a clear result on a 960-patient trial can shape how surgeons use its devices.

If it works: If the trial shows fewer patients develop atrial fibrillation, AtriCure could point to evidence that supports broader use of its devices during cardiac surgery.

If it fails: If the trial misses its goal or faces delays, the company may struggle to expand use of these devices, and surgical trials often fail to show the hoped-for benefit.

AI-written from the trial record. Speculative, and not investment advice.

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 960 people

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

Started

Oct 2025

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

65 years and older

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: * Planned and clinically indicated for cardiac surgical procedure requiring cardiac bypass and opening of the pericardium * Age ≥ 65 years and CHA2DS2-VASc ≥ 3 Exclusion Criteria: * Documented history of atrial fibrillation or atrial flutter anytime prior to the cardiac surgery * Prior procedure involving opening the pericardium or entering the pericardial space * Patients undergoing off-pump surgery * Prior LAA occlusion, exclusion, or removal (surgical or percutaneous) * Presence of a permanent pacemaker * Infiltrative cardiomyopathies (i.e. amyloidosis) * Planned cardiac surgical procedure using non-sternotomy approaches * Patients whose planned procedure is a heart transplant or implantation of any long-term ventricular assist devices * Presence of ventricular arrhythmia * Active endocarditis * NYHA Class IV heart failure symptoms * Preoperative need for an intra-aortic ballon pump or intravenous inotropes * Active systemic infection at the time of cardiac surgery requiring antibiotics * Known allergy to Nitinol or nickel sensitivity * Known medical condition with expected survival of less than 1 year * Other comorbidities that in the Investigator's opinion make the subject unsuitable candidate to complete the protocol required intervention or visits * Current enrollment in an investigation or trial or an investigational devices or investigational drug that would interfere with this trial * Mental impairment or other psychiatric conditions which may not allow the patient to understand the nature, significance, and scope of the trial. * Pregnancy * Known severe symptomatic carotid disease

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Conditions

The condition(s) this trial relates to.

atrial fibrillation prevention target

As listed by the trial registrant

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

Atrial fibrillation, postoperative Post-operative 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

    27 sites in 2 countries. 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

  • Allegheny-Singer Research Institute

    RECRUITING

    Pittsburgh, Pennsylvania, 15212, United States

  • Ascension Saint Thomas

    RECRUITING

    Nashville, Tennessee, 37205, United States

  • Aspirus Hospital

    RECRUITING

    Wausau, Wisconsin, 54401, United States

  • Baylor Research Institute - Baylor Scott and White Research Institute

    RECRUITING

    Dallas, Texas, 75204, United States

  • Bethesda North Hospital

    RECRUITING

    Cincinnati, Ohio, 45242, United States

  • Charleston Area Medical Center

    RECRUITING

    Charleston, West Virginia, 25304, United States

  • Cleveland Clinic Foundation

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Corewell Health

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30308, United States

  • Hamilton General Hospital

    RECRUITING

    Hamilton, Ontario, L8L 2X2, Canada

  • London Health Sciences Centre, University Hospital

    RECRUITING

    London, Ontario, N6A 5A5, Canada

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • MedStar Health Research Institute

    RECRUITING

    Baltimore, Maryland, 21218, United States

  • Montreal Heart Institute

    RECRUITING

    Montreal, Quebec, H1T 1C8, Canada

  • Morton Plant Hospital - BayCare Health System, Inc.

    RECRUITING

    Clearwater, Florida, 33759, United States

  • New York Presbyterian Hospital/Columbia University Irving Medical Center

    NOT_YET_RECRUITING

    New York, New York, 10032, United States

  • Northwell Health

    RECRUITING

    Manhasset, New York, 11030, United States

  • Northwestern Memorial Hospital

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Norton Healthcare

    RECRUITING

    Louisville, Kentucky, 40205, United States

  • Orlando Health, Inc.

    RECRUITING

    Orlando, Florida, 32806, United States

  • Piedmont Hospital

    RECRUITING

    Atlanta, Georgia, 30309, United States

  • Sarasota Memorial Hospital

    RECRUITING

    Sarasota, Florida, 34239, United States

  • Sharp Memorial Hospital

    RECRUITING

    San Diego, California, 92123, United States

  • St. Bernards Medical Center

    RECRUITING

    Jonesboro, Arkansas, 72401, United States

  • St. Joseph's Hospital - BayCare Health System, Inc.

    RECRUITING

    Clearwater, Florida, 33759, United States

  • Trinity Health

    RECRUITING

    Ypsilanti, Michigan, 48197, United States

  • Wellstar Health System

    RECRUITING

    Marietta, Georgia, 30062, United States

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