The Impact of Expandable Cryoballoon on Autonomic Control of the Heart

September 23, 2023 updated by: Piotr Niewinski, MD, Wroclaw Medical University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
difference in the rate of persistent parasympathetic modulation
Time Frame: 3 months
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
Time Frame: 12 months
days
12 months
difference in left atrial dwell time
Time Frame: periprocedural
minutes
periprocedural
difference in radiation dose
Time Frame: periprocedural
mGy
periprocedural
difference in contrast volume
Time Frame: periprocedural
mililiters
periprocedural

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wroclaw Medical University

Collaborators

Boston Scientific Corporation

Investigators

  • Principal Investigator: Piotr Niewinski, MD, PhD, Wroclaw Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

September 17, 2023

First Submitted That Met QC Criteria

September 23, 2023

First Posted (Actual)

September 25, 2023

Study Record Updates

Last Update Posted (Actual)

September 25, 2023

Last Update Submitted That Met QC Criteria

September 23, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POLARxFIT and GPs

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD that underlie results in a publication

IPD Sharing Time Frame

after study completion

IPD Sharing Access Criteria

upon reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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