The Impact of Expandable Cryoballoon on Autonomic Control of the Heart

Wroclaw Medical University

Status: Enrolling

Conditions: Paroxysmal Atrial Fibrillation

Treatments: Device: cryoablation of atrial fibrillation using expandable balloon (28 / 31 mm); Device: cryoablation of atrial fibrillation using only 28 mm size balloon

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06053606

POLARxFIT and GPs

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

expandable cryoballoon

Experimental group

Description:

POLARxFIT

Treatment:

Device: cryoablation of atrial fibrillation using expandable balloon (28 / 31 mm)

standard cryoballoon

Experimental group

Description:

POLARx

Treatment:

Device: cryoablation of atrial fibrillation using only 28 mm size balloon