The Impact of Expandable Cryoballoon on Autonomic Control... | NCT06053606

Studies
The Impact of Expandable Cryoballoon on Autonomic Control of the Heart

NCT06053606

Sponsor

Wroclaw Medical University

Status

Recruiting

Last Update Posted

Jul 24, 2025Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Paroxysmal Atrial Fibrillation

Interventions

cryoablation of atrial fibrillation using only 28 mm size balloon
cryoablation of atrial fibrillation using expandable balloon (28 / 31 mm)

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 10, 2024Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Sep 17, 2023

First Submission Date that Met QC Criteria

Sep 23, 2023

First Posted Date

Sep 25, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 20, 2025

Last Update Posted Date

Jul 24, 2025Actual

Name	Class
Boston Scientific Corporation	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
expandable cryoballoon	Experimental	POLARxFIT	Device: cryoablation of atrial fibrillation using expandable balloon (28 / 31 mm)
standard cryoballoon	Experimental	POLARx	Device: cryoablation of atrial fibrillation using only 28 mm size balloon

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cryoablation of atrial fibrillation using only 28 mm size balloon	Device	all applications in all PVs are done with 28 mm balloon	standard cryoballoon

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
difference in time to first AF episode	days	12 months
difference in left atrial dwell time	minutes	periprocedural

Other Outcomes

Measure	Description	Time Frame
occurence of persistent phrenic nerve palsy	event rate (%)	periprocedural

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Piotr Niewinski, MD, PhD	Contact	+48 71 733 1112		piotr.niewinski@umw.edu.pl

Overall Officials

Name	Affiliation	Role
Piotr Niewinski, MD, PhD	Wroclaw Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Heart Diseases, Wroclaw Medical University	Recruiting	Wroclaw	Lower Silesian Voivodeship	50-556	Poland

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

IPD that underlie results in a publication

Types

Not provided

Time Frame

after study completion

Access Criteria

upon reasonable request

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided