New freezing device tackles stubborn heart rhythm disorder

NCT ID NCT04061603

Completed Disease control Sponsor: Adagio Medical Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 2 times

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.

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.

atrial fibrillation persistent atrial fibrillation

As listed by the trial registrant

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

PERSISTENT ATRIAL FIBRILLATION

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

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