NCT06053606Active, not recruiting
The Impact of Expandable Cryoballoon on Autonomic Control of the Heart
The Impact of Cryoablation Using Expandable (POLARxFIT) vs. Standard Size (POLARx) Balloon on Autonomic Control of the Heart
Source: ClinicalTrials.gov · Last updated 10 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 17 Sept 2023
- Start date
- 10 May 2024
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Wroclaw Medical University
- Diseases
- Atrial fibrillation
- NCT number
- NCT06053606
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 10 May 2024 to the primary completion date, 31 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previous cardioneuroablation procedure
Other illness
- intrinsic sinus node disease
Lab values
- LVEF \<40%
Other
- LA diameter \<38 mm or \>50 mm
- advanced atrioventricular block (PR interval \>300 ms, II or III degree AV block)
- pregnancy
- contraindications to anticoagulation treatment
- any other clinical contraindications to PVI
- known atropine intolerance
Who the study is looking for
- primary PVI
- paroxysmal atrial fibrillation
- sinus rhythm at the admission
- participant meets clinical criteria for PVI
Age in the registry: 18 years to 79 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute of Heart Diseases, Wroclaw Medical University Coordinator of this site? Confirm its status | Wroclaw | Poland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.