NCT06053606 The Impact of Expandable Cryoballoon on Autonomic Control of the Heart
| NCT ID | NCT06053606 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wroclaw Medical University |
| Condition | Paroxysmal Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-05-10 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-05-10 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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). 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.
Eligibility Criteria
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
Contact & Investigator
Piotr Niewinski, MD, PhD
PRINCIPAL INVESTIGATOR
Wroclaw Medical University
Frequently Asked Questions
Who can join the NCT06053606 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 79 Years, studying Paroxysmal Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06053606 currently recruiting?
Yes, NCT06053606 is actively recruiting participants. Contact the research team at piotr.niewinski@umw.edu.pl for enrollment information.
Where is the NCT06053606 trial being conducted?
This trial is being conducted at Wroclaw, Poland.
Who is sponsoring the NCT06053606 clinical trial?
NCT06053606 is sponsored by Wroclaw Medical University. The principal investigator is Piotr Niewinski, MD, PhD at Wroclaw Medical University. The trial plans to enroll 100 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.