Actively Recruiting
The Impact of Expandable Cryoballoon on Autonomic Control of the Heart
Led by Wroclaw Medical University · Updated on 2025-07-24
100
Participants Needed
1
Research Sites
137 weeks
Total Duration
On this page
Sponsors
W
Wroclaw Medical University
Lead Sponsor
B
Boston Scientific Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Impact of Expandable Cryoballoon on Autonomic Control of the Heart
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Primary pulmonary vein isolation (PVI)
- Paroxysmal atrial fibrillation
- Sinus rhythm at admission
- Meets clinical criteria for PVI
You will not qualify if you...
- Left atrium diameter less than 38 mm or greater than 50 mm
- Left ventricular ejection fraction less than 40%
- Intrinsic sinus node disease
- Advanced atrioventricular block (PR interval greater than 300 ms, second or third degree AV block)
- Previous cardioneuroablation procedure
- Pregnancy
- Contraindications to anticoagulation treatment
- Any other clinical contraindications to PVI
- Known atropine intolerance
AI-Screening
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Trial Site Locations
Total: 1 location
1
Institute of Heart Diseases, Wroclaw Medical University
Wroclaw, Lower Silesian Voivodeship, Poland, 50-556
Actively Recruiting
Research Team
P
Piotr Niewinski, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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