N/A
Completed N=20
Effect of a Bigger Cryoballoon on the Total Antral Lesion Size: Evaluation of POLARx FIT
Source: ClinicalTrials.gov NCT05881733 ↗Enrolled (actual)
20
Serious AEs
5.0%
Results posted
Dec 2025
Primary outcomePrimary: Percentage of Ablated Left Atrial Posterior Wall With a 31 mm Balloon Size POLARx FIT — 35.4 percentage of posterior wall
Summary
The investigators will prospectively evaluate the extent of antral lesion created by the 31 mm balloon size of a novel cryoballoon catheter (POLARx FIT). In 20 patients with paroxysmal atrial fibrillation, the investigators will perform pre- and post-ablation high-definition 3D maps to quantify the extent of lesion created by the 31 mm POLARx FIT cryoballoon.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Ablated Left Atrial Posterior Wall With a 31 mm Balloon Size POLARx FIT |
35.4 | — |
| SECONDARY Percentage of Pulmonary Veins With Grade 4 Occlusion With a 31 mm Balloon Size POLARx FIT |
86 | — |
| SECONDARY Percentage of Pulmonary Veins With a Single Shot Success Rate Using a 31 mm Balloon Size POLARx FIT Cryoablation Catheter |
79 | — |
Eligibility Criteria
Inclusion Criteria
- History of symptomatic paroxysmal AF
- Subjects who are indicated for a PVI according to the 2020 ESC guidelines for the diagnosis and management of AF
- Subjects who are willing and capable of providing informed consent
- Subjects who are willing and capable of participating in all testing associated with this clinical investigation
- Subjects whose age is 18 years or above
Exclusion Criteria
- Any known contraindication to an AF ablation or anticoagulation
- History of previous left atrial ablation or surgical treatment of AF, atrial flutter, or atrial tachycardia
- AF secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause
- Significant structural heart disease as evidenced by:
- Left ventricular ejection fraction 55 mm based on most recent TTE performed 24 mm defined by CT-scan
- Pregnant, lactating, or women of childbearing potential who are, or plan to become, pregnant during the time of the study
- Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study
Data sourced from ClinicalTrials.gov (NCT05881733). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.