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

NCT05881733 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-12-04

Study results available
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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.

Conditions

Interventions

DEVICE

POLARx FIT cryoballoon

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

Sponsors & Collaborators

Principal Investigators

  • Sing-Chien Yap, MD, PhD · Erasmus Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-02
Primary Completion
2024-04-29
Completion
2025-04-23

Countries

  • Netherlands

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05881733 on ClinicalTrials.gov