Image

The Impact of Expandable Cryoballoon on Autonomic Control of the Heart

The Impact of Expandable Cryoballoon on Autonomic Control of the Heart

Recruiting
18-79 years
All
Phase N/A
  • Technical (Original)
  • Simplified (AI rewritten)

Powered by AI

Overview

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.

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

Study details
    Paroxysmal Atrial Fibrillation

NCT06053606

Wroclaw Medical University

3 August 2025

Contact a study center
Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.