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Frozen heart fix: new device targets AFib

NCT ID NCT05416086

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 tested a medical device that freezes small areas of heart tissue to treat atrial fibrillation (AFib) and related irregular heartbeats. The goal was to see if the procedure safely stops abnormal rhythms for at least 12 months. The study enrolled 91 people, but was terminated early, so the full results are not available.

What this could mean

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

Active substance
cryoablation procedure using the iCLAS Cryoablation System
What this could lead to
If successful, this could offer a safe and effective way to freeze abnormal heart tissue and restore normal rhythm in people with atrial fibrillation.
What could go wrong
The study was terminated early, so results are limited. Cryoablation carries risks like heart tissue damage or blood clots, and the procedure may not prevent future arrhythmias.

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

91 people

The number who actually took part.

Started

Sep 2021

Finished

Jan 2025

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

18 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: * Subject is ≥ 18 years of age * Planned ablation procedure according to the indication for use of the commercially available Adagio iCLAS™ Cryoablation System * Subject willing to comply with study requirements and give informed consent. Exclusion Criteria: * In the opinion of the Investigator, any known contraindication to an atrial ablation procedure with the Adagio iCLAS™ Cryoablation System as indicated in the device Instructions For Use (IFU). * Subject is enrolled in a study that has not been approved for concurrent enrollment by the sponsor. * Any other condition that, in the judgment of the investigator, makes the patient a poor candidate for this procedure, the study or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, terminal illness with a life expectancy of less than one year, extensive travel away from the research center)

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Conditions

The condition(s) this trial relates to.

atrial fibrillation atrial flutter paroxysmal atrial fibrillation persistent atrial fibrillation

As listed by the trial registrant

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

Atrial fibrillation Atrial flutter Paroxysmal atrial fibrillation Persistent atrial fibrillation

Contacts and locations

Locations

  • Erasmus MC

    Rotterdam, Netherlands

  • Onze-Lieve-Vrouw Hospital Aalst (OLV)

    Aalst, 9300, Belgium

  • St. Antonius Ziekenhuis

    Nieuwegein, 3435, Netherlands

  • Universitatsklinikum Erlangen

    Erlangen, 91054, Germany

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