The Impact of Expandable Cryoballoon on Autonomic Control of the Heart
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: cryoablation of atrial fibrillation using only 28 mm size balloon, cryoablation of atrial fibrillation using expandable balloon (28 / 31 mm).
- Who it may be relevant to
- Registry conditions: Paroxysmal Atrial Fibrillation. Basic parameters: 18 years — 79 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Impact of Cryoablation Using Expandable (POLARxFIT) vs. Standard Size (POLARx) Balloon on Autonomic Control of the Heart
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.
Interventions
- Device cryoablation of atrial fibrillation using only 28 mm size balloon
all applications in all PVs are done with 28 mm balloon - Device cryoablation of atrial fibrillation using expandable balloon (28 / 31 mm)
first applications in LSPV and RSPV are done with 31 mm balloon
Primary outcome measures
- difference in the rate of persistent parasympathetic modulation [Time frame: 3 months]
Secondary outcome measures (4)
- difference in time to first AF episode [Time frame: 12 months]
- difference in left atrial dwell time [Time frame: periprocedural]
- difference in radiation dose [Time frame: periprocedural]
- difference in contrast volume [Time frame: periprocedural]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Poland · 1 center
- Institute of Heart Diseases, Wroclaw Medical University — Wroclaw
Identifiers
NCT: NCT06053606 · POLARxFIT and GPs