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

NCT ID NCT06989775

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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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