Using a new cryoballoon to improve heart control in atrial fibrillation patients
The Impact of Cryoablation Using Expandable (POLARxFIT) vs. Standard Size (POLARx) Balloon on Autonomic Control of the Heart
This study is testing a new cryoballoon treatment for people with atrial fibrillation to see if it can help their heart function better compared to a standard cryoballoon.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Sponsor | Wroclaw Medical University Academic / other |
| Locations | 1 site (Wroclaw, Lower Silesian Voivodeship) |
| Trial ID | NCT06053606 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of an expandable cryoballoon (POLARxFIT) compared to a standard cryoballoon (POLARx) on the autonomic control of the heart in patients with paroxysmal atrial fibrillation. Approximately 40% of patients experience parasympathetic denervation after cryoballoon ablation, which is associated with better outcomes. The hypothesis is that the larger size and positioning of the POLARxFIT balloon may enhance autonomic modulation, potentially leading to improved clinical efficacy. Participants will undergo cryoablation using either balloon type to assess these effects.
Who should consider this trial
Good fit: Ideal candidates include individuals with paroxysmal atrial fibrillation who meet specific clinical criteria for pulmonary vein isolation.
Not a fit: Patients with significant heart conditions, such as advanced atrioventricular block or intrinsic sinus node disease, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better management of atrial fibrillation and improved heart function for patients.
How similar studies have performed: While the specific approach of using the POLARxFIT balloon is novel, previous studies have shown promising results with cryoablation techniques in managing atrial fibrillation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Wroclaw, Lower Silesian Voivodeship
- Institute of Heart Diseases, Wroclaw Medical University — Wroclaw, Lower Silesian Voivodeship, Poland (Recruiting)
Study contacts
- Principal investigator: Piotr Niewinski, MD, PhD — Wroclaw Medical University
- Study coordinator: Piotr Niewinski, MD, PhD
- Email: piotr.niewinski@umw.edu.pl
- Phone: +48 71 733 1112
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.