Bigger balloon, better burn? new study maps heart lesions

NCT ID NCT05881733

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 ยท Last updated Jun 27, 2026

Summary

This study tested a larger 31 mm cryoballoon in 20 patients with paroxysmal atrial fibrillation to see how much heart tissue it could freeze. Researchers used 3D maps before and after the procedure to measure the size of the treated area. The goal was to gather data to improve future ablation procedures, not to directly treat the condition.

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

20 people

The number who actually took part.

Started

Oct 2023

Finished

Apr 2025

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

18 years and older

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: 1. History of symptomatic paroxysmal AF 2. Subjects who are indicated for a PVI according to the 2020 ESC guidelines for the diagnosis and management of AF 3. Subjects who are willing and capable of providing informed consent 4. Subjects who are willing and capable of participating in all testing associated with this clinical investigation 5. Subjects whose age is 18 years or above Exclusion Criteria: 1. Any known contraindication to an AF ablation or anticoagulation 2. History of previous left atrial ablation or surgical treatment of AF, atrial flutter, or atrial tachycardia 3. AF secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause 4. Significant structural heart disease as evidenced by: 1. Left ventricular ejection fraction \<45% based on most recent transthoracic echocardiogram (TTE) performed \<6 months prior to enrollment 2. LA diameter \>55 mm based on most recent TTE performed \<6 months prior to enrollment 3. Previous cardiac surgery 4. Previous cardiac valvular surgical or percutaneous procedure 5. Interatrial baffle, closure device, patch, or occluder 6. Unstable angina or ongoing myocardial ischemia 7. Moderate or severe valvular heart disease on most recent TTE performed \<6 months prior to enrolment 8. Congenital heart disease 9. Left atrial thrombus 5. History of blood clotting or bleeding disease 6. Stroke or transient ischemic attack \<3 months prior to enrollment 7. Active systemic infection 8. Common ostium PV \>24 mm defined by CT-scan 9. Pregnant, lactating, or women of childbearing potential who are, or plan to become, pregnant during the time of the study 10. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Erasmus Medical Center

    Rotterdam, South Holland, 3015 GD, Netherlands

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