Bigger balloon, better burn? new study maps heart lesions
NCT ID NCT05881733
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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20 people
The number who actually took part.
- Started
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Oct 2023
- Finished
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Apr 2025
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Erasmus Medical Center
Rotterdam, South Holland, 3015 GD, Netherlands
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- High-resolution Contrast-Enhanced MRI of atrial fibrillation patients prior to FIRM ablation
- Apple watch vs. medical monitor: which better detects hidden heart rhythm problems?
- Can a new ultrasound catheter give doctors a better view inside the heart?
- Can dropping one blood thinner cut bleeding without raising heart risks?
- Hidden heart rhythm problems after stroke: can longer monitoring prevent a second stroke?
- Can a blood test reveal why atrial fibrillation returns after cryoablation?