The Impact of Expandable Cryoballoon on Autonomic Control of the Heart

Not Applicable

Recruiting

• Conditions: Paroxysmal Atrial Fibrillation
• Interventions: Device: cryoablation of atrial fibrillation using only 28 mm size balloon; Device: cryoablation of atrial fibrillation using expandable balloon (28 / 31 mm)

• Registration Number: NCT06053606
• Lead Sponsor: Wroclaw Medical University

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

Not available

Study Timeline

• Study First Submitted: 2023-09-17
• Study First Submitted QC: 2023-09-23
• Study First Posted: 2023-09-25
• Status Verified: 2024-05
• Study Start: 2024-05-10
• Last Update Submitted: 2024-05-14
• Last Update Posted: 2024-05-16
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard cryoballoon	cryoablation of atrial fibrillation using only 28 mm size balloon	POLARx
expandable cryoballoon	cryoablation of atrial fibrillation using expandable balloon (28 / 31 mm)	POLARxFIT

Primary Outcome Measures

Name	Time	Method
difference in the rate of persistent parasympathetic modulation	3 months	defined as decrease in RR interval of \>20%

Secondary Outcome Measures

Name	Time	Method
difference in time to first AF episode	12 months	days
difference in radiation dose	periprocedural	mGy
difference in left atrial dwell time	periprocedural	minutes
difference in contrast volume	periprocedural	mililiters

Trial Locations

Locations (1)

Institute of Heart Diseases, Wroclaw Medical University; 🇵🇱 Wroclaw, Dolnoslaskie, Poland