New freezing device tackles stubborn heart rhythm disorder

NCT ID NCT04061603

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a device called iCLAS™ that uses extreme cold to destroy tiny areas of heart tissue causing persistent atrial fibrillation (AFib). 215 adults with AFib lasting more than 7 days but less than a year received the procedure. Researchers tracked safety issues like heart damage or stroke, and checked if the heart stayed in normal rhythm after a single treatment.

What this could mean

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

Active substance

Cryoablation device (iCLAS™)

What this could lead to

If successful, this could provide a new treatment option to control persistent atrial fibrillation and reduce symptoms.

What could go wrong

This is a completed study, but results are not yet published. The procedure carries risks like heart damage, bleeding, or stroke. It is not a cure, and some patients may still need medication or repeat procedures.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

atrial fibrillation persistent atrial fibrillation

As listed by the trial registrant

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

Contacts and locations

Locations

  • Banner Health

    Phoenix, Arizona, 85006, United States

  • Baylor St. Luke's Medical Center

    Houston, Texas, 77030, United States

  • Emory St. Joseph's Hospital

    Atlanta, Georgia, 30342, United States

  • Erasmus University Medical Center

    Rotterdam, 3015 GD, Netherlands

  • Grandview Medical Center

    Birmingham, Alabama, 35243, United States

  • Johns Hopkins University

    Baltimore, Maryland, 21205, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    Jacksonville, Florida, 32224, United States

  • New Mexico Heart Institute

    Albuquerque, New Mexico, 87102, United States

  • Northwestern University

    Evanston, Illinois, 60208, United States

  • Ohio Health Research Institute

    Columbus, Ohio, 43214, United States

  • Onze Lieve Vrouwziekenhuis

    Aalst, Belgium

  • Prairie Heart Research Institute

    Springfield, Illinois, 62701, United States

  • South Denver Cardiology Associates

    Denver, Colorado, 80120, United States

  • Southlake Regional Medical Centre

    Newmarket, Ontario, L3Y 2P9, Canada

  • St. Antonius Ziekenhuis Nieuwegein

    Nieuwegein, Netherlands

  • St. Bernards Medical Center

    Jonesboro, Arkansas, 72401, United States

  • Staten Island University Hospital - Northwell Health

    Staten Island, New York, 10305, United States

  • The Valley Hospital

    Ridgewood, New Jersey, 07450, United States

  • University of California San Diego

    San Diego, California, 92093, United States

  • ZNA Middelheim

    Antwerp, Belgium