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Can a single freeze procedure tame stubborn atrial fibrillation?

NCT ID NCT05507749

Disease control Sponsor: Seoul National University Hospital 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This trial tests whether cryoablation, a procedure that freezes heart tissue to block faulty electrical signals, can control early persistent atrial fibrillation (AF) when used as the first treatment. Participants have symptomatic AF that has lasted between 7 days and 3 years and has not responded to medication. The study uses a small implanted monitor to continuously track heart rhythm for a year, comparing the time spent in AF before and after the procedure to see if the ablation meaningfully reduces the burden of the condition.

What this could mean

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

Active substance
cryoballoon ablation
What this could lead to
If successful, this could show that a single cryoablation procedure effectively controls early persistent atrial fibrillation, potentially reducing the need for repeat procedures or long-term medication.
What could go wrong
The trial is relatively small and early, and results may not apply to all patients. Risks include procedural complications, incomplete isolation, or recurrence of arrhythmia despite the procedure.

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

130 people

The number who actually took part.

Started

Nov 2020

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 79 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: * Drug refractory symptomatic persistent atrial fibrillation diagnosed within 3 years * Either two conditions 1. atrial fibrillation episode lasting longer than 7 days, but less than 3 years documented by consecutive electrocardiogram recordings of 100% atrial fibrillation greater than 7 days apart or 2. atrial fibrillation episode requiring electrical or pharmacological cardioversion after 24 hours of atrial fibrillation documented by continuous recording * Willing to comply with study requirements and give informed consent to participate in this clinical study Exclusion Criteria: * Long-standing persistent atrial fibrillation more than 3 years * Sinus rhythm at enrollment * Recurrent sinus rhythm after electrical cardioversion * Severe left ventricular dysfuncion (left ventricle ejection fraction \< 30%) * Previous ablation procedure or surgery for atrial fibrillation * Contraindication to chronic anticoagulation therapy or heparin * Documented left atrial diameter \>50 mm from parasternal long-axis view * A percutaneous coronary intervention or myocardial infarction ≤3 months * A stroke or transient ischemic attack ≤6 months * Planned cardiovascular intervention * Mental or physical inability to participate in the study * Participation in another randomized clinical trial * Uncontrolled hypertension, untreated hypothyroidism or hyperthyroidism * Requirement for dialysis due to terminal renal failure

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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.

Atrial fibrillation, persistent

Contacts and locations

Locations

  • Seoul National university Hostpital

    Seoul, Jongno-gu, 03080, South Korea

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