Effect of a Bigger Cryoballoon on the Total Antral Lesion Size: Evaluation of POLARx FIT

Sponsor
Erasmus Medical Center
Study ID
NCT05881733
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • POLARx FIT cryoballoon — DEVICE
    Patients will undergo cryoablation with the 31 mm balloon size of the POLARx FIT cryoballoon.

Study Details

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.

Key Dates

Start date
Oct 2, 2023
Status verified
Nov 2025
Primary completion
Apr 29, 2024
Completion
Apr 23, 2025

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Study population
    This study will have only a single arm. Patients will undergo pulmonary vein isolation using the 31 mm balloon size of POLARx FIT. High-definition 3D maps will be constructed before and after cryoablation to assess the antral lesion size.

Primary Outcome Measure

Percentage of Ablated Left Atrial Posterior Wall With a 31 mm Balloon Size POLARx FIT [ Time Frame: Interprocedural (directly after cryoablation) ]

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