The Impact of Expandable Cryoballoon on Autonomic Control of the Heart

Paroxysmal Atrial Fibrillation Clinical Trial

Official title:

The Impact of Cryoablation Using Expandable (POLARxFIT) vs. Standard Size (POLARx) Balloon on Autonomic Control of the Heart

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06053606
• Other study ID #: POLARxFIT and GPs
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: May 2024
• Source: Wroclaw Medical University
• Contact: Piotr Niewinski, MD, PhD
• Phone: +48 71 733 1112
• Email: piotr.niewinski[@]umw.edu.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Device:
• cryoablation of atrial fibrillation using only 28 mm size balloon
all applications in all PVs are done with 28 mm balloon
• cryoablation of atrial fibrillation using expandable balloon (28 / 31 mm)
first applications in LSPV and RSPV are done with 31 mm balloon

Locations

Country	Name	City	State
Poland	Institute of Heart Diseases, Wroclaw Medical University	Wroclaw	Dolnoslaskie

Sponsors (2)

Lead Sponsor	Collaborator
Wroclaw Medical University	Boston Scientific Corporation

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	occurence of persistent phrenic nerve palsy	event rate (%)	periprocedural
Primary	difference in the rate of persistent parasympathetic modulation	defined as decrease in RR interval of >20%	3 months
Secondary	difference in time to first AF episode	days	12 months
Secondary	difference in left atrial dwell time	minutes	periprocedural
Secondary	difference in radiation dose	mGy	periprocedural
Secondary	difference in contrast volume	mililiters	periprocedural