Paroxysmal Atrial FibrillationNCT06053606
The Impact of Expandable Cryoballoon on Autonomic Control of the Heart
A study testing cryoablation of atrial fibrillation using only 28 mm size balloon and cryoablation of atrial fibrillation using expandable balloon (28 / 31 mm) in people with Paroxysmal Atrial Fibrillation, run by Wroclaw Medical University at 1 site in Poland.
Trial summary
Approximately 40% of patients following cryoballoon ablation show signs of parasympathetic denervation. The presence of such effect is related to better outcomes in terms of clinical efficacy (freedom from atrial fibrillation). Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- cryoablation of atrial fibrillation using only 28 mm size balloon and cryoablation of atrial fibrillation using expandable balloon (28 / 31 mm)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 10 May 2024to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary PVI
- paroxysmal atrial fibrillation
- sinus rhythm at the admission
- participant meets clinical criteria for PVI
Who cannot join
- 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
Show all 9Show fewer
- contraindications to anticoagulation treatment
- any other clinical contraindications to PVI
- known atropine intolerance
Trial locations and contacts
1 site in 1 country.
Poland1 site
Institute of Heart Diseases, Wroclaw Medical University
Wroclaw, Lower Silesian Voivodeship, 50-556
About this study
Official title: The Impact of Cryoablation Using Expandable (POLARxFIT) vs. Standard Size (POLARx) Balloon on Autonomic Control of the Heart
Approximately 40% of patients following cryoballoon ablation show signs of parasympathetic denervation. The presence of such effect is related to better outcomes in terms of clinical efficacy (freedom from atrial fibrillation). It could be hypothesized that larger sized balloon (POLARxFIT system) because of more antral position within the left atrium (and hence smaller distance from ganglionated plexi) might enhance this beneficial modulation of the autonomic system of the heart. This study intends to compare the effects of cryoablation employing expandable balloon (POLARxFIT) vs. standard balloon (POLARx) on autonomic system of the heart.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- cryoablation of atrial fibrillation using only 28 mm size balloon, cryoablation of atrial fibrillation using expandable balloon (28 / 31 mm)
- Keywords
- atrial fibrillation, ganglionated plexus, autonomic modulation, cryoablation, cryoballoon, expandable balloon
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryoablation of atrial fibrillation using only 28 mm size balloonDevice
all applications in all PVs are done with 28 mm balloon
cryoablation of atrial fibrillation using expandable balloon (28 / 31 mm)Device
first applications in LSPV and RSPV are done with 31 mm balloon
| Study group | Role | What they receive |
|---|---|---|
| expandable cryoballoon | Experimental | POLARxFIT Receives: Device: cryoablation of atrial fibrillation using expandable balloon (28 / 31 mm) |
| standard cryoballoon | Experimental | POLARx Receives: Device: cryoablation of atrial fibrillation using only 28 mm size balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in the rate of persistent parasympathetic modulation
defined as decrease in RR interval of >20%
Measured: 3 months
Secondary outcomes (4)
difference in time to first AF episode
days
Measured: 12 months
difference in left atrial dwell time
minutes
Measured: periprocedural
difference in radiation dose
mGy
Measured: periprocedural
difference in contrast volume
mililiters
Measured: periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start10 May 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Principal investigator, Piotr Niewinski, MD, Wroclaw Medical University
- Investigators
- Piotr Niewinski, MD, PhD, Principal investigator, Wroclaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06053606
- Sponsor's protocol ID
- POLARxFIT and GPs
- Status last verified
- Aug 2026
- First submitted
- 17 Sep 2023
- Last updated
- 10 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Cryoablation Using Expandable (POLARxFIT) vs. Standard Size (POLARx) Balloon on Autonomic Control of the Heart
- ClinicalTrials.gov ID
- NCT06053606
- Acronym / sponsor ID
- POLARxFIT and GPs
- Conditions
- Paroxysmal Atrial Fibrillation
- Keywords
- atrial fibrillation, ganglionated plexus, autonomic modulation, cryoablation, cryoballoon, expandable balloon
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 10 May 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 25 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Approximately 40% of patients following cryoballoon ablation show signs of parasympathetic denervation. The presence of such effect is related to better outcomes in terms of clinical efficacy (freedom from atrial fibrillation). It could be hypothesized that larger sized balloon (POLARxFIT system) because of more antral position within the left atrium (and hence smaller distance from ganglionated plexi) might enhance this beneficial modulation of the autonomic system of the heart. This study intends to compare the effects of cryoablation employing expandable balloon (POLARxFIT) vs. standard balloon (POLARx) on autonomic system of the heart.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| expandable cryoballoon | Experimental | Device: cryoablation of atrial fibrillation using expandable balloon (28 / 31 mm)POLARxFIT |
| standard cryoballoon | Experimental | Device: cryoablation of atrial fibrillation using only 28 mm size balloonPOLARx |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- primary PVI
- paroxysmal atrial fibrillation
- sinus rhythm at the admission
- participant meets clinical criteria for PVI
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cryoablation of atrial fibrillation using only 28 mm size balloonall applications in all PVs are done with 28 mm balloon | Device | standard cryoballoon |
| cryoablation of atrial fibrillation using expandable balloon (28 / 31 mm)first applications in LSPV and RSPV are done with 31 mm balloon | Device | expandable cryoballoon |
Primary outcome
difference in the rate of persistent parasympathetic modulation
Time frame: 3 months
defined as decrease in RR interval of >20%
4 secondary outcomes
difference in time to first AF episode
Time frame: 12 months
difference in left atrial dwell time
Time frame: periprocedural
difference in radiation dose
Time frame: periprocedural
difference in contrast volume
Time frame: periprocedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: Yes. IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Piotr Niewinski, MD, PhD principal investigator
Wroclaw Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cryoablation of atrial fibrillation using only 28 mm size balloon and cryoablation of atrial fibrillation using expandable balloon (28 / 31 mm) in people with Paroxysmal Atrial Fibrillation, run by Wroclaw Medical University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference in the rate of persistent parasympathetic modulation (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.