Status:
RECRUITING
The Impact of Expandable Cryoballoon on Autonomic Control of the Heart
Lead Sponsor:
Wroclaw Medical University
Collaborating Sponsors:
Boston Scientific Corporation
Conditions:
Paroxysmal Atrial Fibrillation
Eligibility:
All Genders
18-79 years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- primary PVI
- paroxysmal atrial fibrillation
- sinus rhythm at the admission
- participant meets clinical criteria for PVI
Exclusion
- 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
Key Trial Info
Start Date :
May 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06053606
Start Date
May 10 2024
End Date
December 31 2026
Last Update
July 24 2025
Active Locations (1)
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1
Institute of Heart Diseases, Wroclaw Medical University
Wroclaw, Lower Silesian Voivodeship, Poland, 50-556