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NCT06053606 Clinical Trial

The Impact of Expandable Cryoballoon on Autonomic Control of the Heart

Paroxysmal Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06053606
Other study ID # POLARxFIT and GPs
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 10, 2024
Est. completion date June 30, 2026

Study information
Verified date May 2024
Source Wroclaw Medical University
Contact Piotr Niewinski, MD, PhD
Phone +48 71 733 1112
Email piotr.niewinski@umw.edu.pl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date June 30, 2026
Est. primary completion date June 30, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 79 Years
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 Design

Related Conditions & MeSH terms

Intervention

Device:
• cryoablation of atrial fibrillation using only 28 mm size balloon
all applications in all PVs are done with 28 mm balloon
• cryoablation of atrial fibrillation using expandable balloon (28 / 31 mm)
first applications in LSPV and RSPV are done with 31 mm balloon

Locations
Country Name City State
Poland Institute of Heart Diseases, Wroclaw Medical University Wroclaw Dolnoslaskie

Sponsors (2)
Lead Sponsor Collaborator
Wroclaw Medical University Boston Scientific Corporation

Country where clinical trial is conducted

Poland, 

Outcome
Type Measure Description Time frame Safety issue
Other occurence of persistent phrenic nerve palsy event rate (%) periprocedural
Primary difference in the rate of persistent parasympathetic modulation defined as decrease in RR interval of >20% 3 months
Secondary difference in time to first AF episode days 12 months
Secondary difference in left atrial dwell time minutes periprocedural
Secondary difference in radiation dose mGy periprocedural
Secondary difference in contrast volume mililiters periprocedural
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