Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New freezing device tackles stubborn heart rhythm disorder

NCT ID NCT04061603

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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.

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

215 people

The number who actually took part.

Started

Dec 2019

Finished

Aug 2024

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 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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 IC1 Male or female between the ages of 18 and 80 years IC2 Currently scheduled for an ablation of symptomatic, PsAF defined as continuous AF that is sustained \> 7-days and ≤ 12 months and documented by the following: a. Physician's note indicating continuous AF \> 7 days and ≤ 12 months, AND b. One of the following: i. 24-hour Holter within 180 days of enrollment showing continuous AF, OR ii. Two electrocardiograms from any forms of rhythm monitoring (e.g., 12-lead ECGs or single lead ECGs) completed ≥ 7 days apart within 180 days of enrollment. IC3 Refractory to at least one class I or III AAD. (Refractory defined as not effective, not tolerated or not desired) IC4 Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study IC5 Willingness and ability to give an informed consent EXCLUSION CRITERIA EC 1 In the opinion of the Investigator, any known contraindication to an atrial ablation, TEE, or anticoagulation. Including, but not limited to, the identification of any atrial thrombus or evidence of sepsis EC 2 Any duration of continuous AF lasting longer than 12-months EC 3 History of previous left atrial ablation or surgical treatment for AF/AFL/AT EC 4 Atrial fibrillation secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause EC 5 Structural heart disease as described below: 1. Left ventricular ejection fraction (LVEF) \< 40% based on most recent TTE 2. Left atrial size \> 55 mm (parasternal long axis view) documented within 6-months of screening 3. NYHA Class III or IV heart failure documented within the previous 12-months 4. An implanted pacemaker or ICD 5. Previous cardiac surgery, ventriculotomy, or atriotomy (excluding atriotomy for CABG), 6. Previous cardiac valvular surgical or percutaneous procedure, or prosthetic valve 7. Interatrial baffle, closure device, patch, or PFO occluder 8. Presence of a left atrial appendage occlusion device 9. Presence of any pulmonary vein stenting devices 10. Coronary artery bypass graft (CABG) or PTCA procedure within 6 months prior to procedure 11. Unstable angina or ongoing myocardial ischemia 12. Myocardial infarction within the previous six (6) months prior to procedure 13. Moderate or severe mitral insufficiency or stenosis based on most recent TTE 14. Atrial myxoma 15. Significant congential anomaly EC 6 BMI \> 40 * BMI \>35 and no prior sponsor approval into the study EC 7 Any previous history of cryoglobulinemia EC 8 History of blood clotting or bleeding disease EC 9 History of severe COPD requiring steroid use in the previous 12-months EC 10 History of severe sleep apnea (AHI \> 30) not currently treated with a CPAP machine or other mechanical device EC 11 Any prior history of documented cerebral infarct including recent TIA (within one year) or systemic embolism (excluding a post-operative DVT) EC 12 Any prior history or current evidence of hemidiaphragmatic paralysis EC 13 Pregnant or lactating (current or anticipated during study follow-up) EC 14 Current enrollment in any other study protocol where testing or results from that study may interfere with the procedure or outcome measurements for this study EC 15 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 two years, extensive travel away from the research center, COVID-19 related concerns)

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Persistent atrial fibrillation are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.