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Could a bigger balloon tame the Heart's electrical chaos?

NCT ID NCT06053606

Disease control Sponsor: Wroclaw Medical University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time

Summary

This trial tests whether using a larger, expandable balloon during cryoablation for paroxysmal atrial fibrillation better affects the heart's autonomic (automatic) control compared to a standard-size balloon. About 40% of patients show signs of beneficial parasympathetic denervation after cryoablation, and a larger balloon may enhance this effect by sitting closer to key nerve clusters. The study enrolls 100 adults with paroxysmal AF who are scheduled for their first pulmonary vein isolation, and it measures changes in heart rate, time to AF recurrence, and procedure details.

What this could mean

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

Active substance
cryoablation using either a standard 28 mm balloon or an expandable 28/31 mm balloon
What this could lead to
If the larger balloon enhances beneficial autonomic modulation, it could improve long-term freedom from atrial fibrillation after ablation.
What could go wrong
This is an early-stage comparison; the larger balloon may not provide extra benefit, and cryoablation carries risks like heart rhythm disturbances or damage to nearby structures.

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

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

Mar 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

18 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: * primary PVI * paroxysmal atrial fibrillation * sinus rhythm at the admission * participant meets clinical criteria for PVI Exclusion Criteria: * LA diameter \<38 mm or \>50 mm * LVEF \<40% * intrinsic sinus node disease * advanced atrioventricular block (PR interval \>300 ms, II or III degree AV block) * previous cardioneuroablation procedure * pregnancy * contraindications to anticoagulation treatment * any other clinical contraindications to PVI * known atropine intolerance

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Conditions

The condition(s) this trial relates to.

atrial fibrillation paroxysmal atrial fibrillation

As listed by the trial registrant

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

Paroxysmal atrial fibrillation

Contacts and locations

Locations

  • Institute of Heart Diseases, Wroclaw Medical University

    Wroclaw, Lower Silesian Voivodeship, 50-556, Poland

More trials for these conditions

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