Ignite Creation Date:
2025-12-26 @ 5:22 PM
Ignite Modification Date:
2025-12-29 @ 6:00 AM
Study NCT ID:
NCT06053606
Status:
RECRUITING
Last Update Posted:
2025-07-24
First Post:
2023-09-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Expandable Cryoballoon on Autonomic Control of the Heart
Sponsor:
Wroclaw Medical University
Organization:
Study Overview
Official Title:
The Impact of Cryoablation Using Expandable (POLARxFIT) vs. Standard Size (POLARx) Balloon on Autonomic Control of the Heart
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: