NCT06053606

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Wroclaw Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Paroxysmal Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	cryoablation of atrial fibrillation using only 28 mm size balloon	all applications in all PVs are done with 28 mm balloon
DEVICE	cryoablation of atrial fibrillation using expandable balloon (28 / 31 mm)	first applications in LSPV and RSPV are done with 31 mm balloon

Timeline

• Start date: 2024-05-10
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2023-09-25
• Last updated: 2025-07-24

Locations

1 site across 1 country: Poland

Regulatory

• FDA-regulated device study