The Impact of Expandable Cryoballoon on Autonomic Control of the Heart

Study Overview
=================
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.

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

Conditions
-----------------
Paroxysmal Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: cryoablation of atrial fibrillation using only 28 mm size balloon
* Device: cryoablation of atrial fibrillation using expandable balloon (28 / 31 mm)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: expandable cryoballoon<br>POLARxFIT | Device: cryoablation of atrial fibrillation using expandable balloon (28 / 31 mm)<br>* first applications in LSPV and RSPV are done with 31 mm balloon<br>|
| Experimental: standard cryoballoon<br>POLARx | Device: cryoablation of atrial fibrillation using only 28 mm size balloon<br>* all applications in all PVs are done with 28 mm balloon<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference in the rate of persistent parasympathetic modulation | defined as decrease in RR interval of >20% | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference in time to first AF episode | days | 12 months | 
| difference in left atrial dwell time | minutes | periprocedural | 
| difference in radiation dose | mGy | periprocedural | 
| difference in contrast volume | mililiters | periprocedural | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atrial fibrillation, ganglionated plexus, autonomic modulation, cryoablation, cryoballoon, expandable balloon