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The Impact of Expandable Cryoballoon on Autonomic Control of the Heart

RECRUITINGN/ASponsored by Wroclaw Medical University
Actively Recruiting
PhaseN/A
SponsorWroclaw Medical University
Started2024-05-10
Est. completion2026-12-31
Eligibility
Age18 Years – 79 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06053606

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.

Eligibility

Age: 18 Years – 79 YearsHealthy volunteers accepted
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

Conditions2

Heart DiseaseParoxysmal Atrial Fibrillation

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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