At a glance
ClinicalIndex Comparison RecordN/ACompleted· 20 enrolled
Drug / intervention
POLARx FIT cryoballoondevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effect of a Bigger Cryoballoon on the Total Antral Lesion Size: Evaluation of POLARx FIT
In Brief
A clinical study evaluating POLARx FIT cryoballoon for Atrial Fibrillation. Completed, enrolled 20 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation
CountriesNetherlands
CollaboratorsBoston Scientific Corporation
Timeline
N/ACompletedFinished
202420252026
First PostedMay 2023
Enrollment StartOct 2023
Primary CompletionApr 2024
Study CompletionApr 2025
TodayJul 2026
First PostedMay 31, 2023
Enrollment StartOct 2, 2023
Primary CompletionApr 29, 2024
Study CompletionApr 23, 2025
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 3.1 years ago
Interventions
POLARx FIT cryoballoondevice
Patients will undergo cryoablation with the 31 mm balloon size of the POLARx FIT cryoballoon.