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

NCT05881733 | Completed Results

• 2 other identifiers: MEC-2023-0325NL84423.078.23
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Atrial Fibrillation

Keywords

Cryoballoon; Atrial fibrillation

Outcome Measures

Primary Outcomes (1)

• Percentage of Ablated Left Atrial Posterior Wall With a 31 mm Balloon Size POLARx FIT

  Low-voltage areas will be quantified using a bipolar voltage \<0.3 mV. The sum of the posterior ablated areas of all pulmonary veins is expressed as a percentage of the total left atrial posterior wall.

  Interprocedural (directly after cryoablation)

Secondary Outcomes (2)

• Percentage of Pulmonary Veins With Grade 4 Occlusion With a 31 mm Balloon Size POLARx FIT

  Interprocedural (before cryoablation)

• Percentage of Pulmonary Veins With a Single Shot Success Rate Using a 31 mm Balloon Size POLARx FIT Cryoablation Catheter

  Interprocedural (directly after cryoablation)

Study Arms (1)

Study population

OTHER

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.

Device: POLARx FIT cryoballoon

Interventions

POLARx FIT cryoballoon DEVICE

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

Study population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 \<45% based on most recent transthoracic echocardiogram (TTE) performed \<6 months prior to enrollment
• LA diameter \>55 mm based on most recent TTE performed \<6 months prior to enrollment
• Previous cardiac surgery
• Previous cardiac valvular surgical or percutaneous procedure
• Interatrial baffle, closure device, patch, or occluder
• Unstable angina or ongoing myocardial ischemia
• Moderate or severe valvular heart disease on most recent TTE performed \<6 months prior to enrolment
• Congenital heart disease
• Left atrial thrombus
• History of blood clotting or bleeding disease
• Stroke or transient ischemic attack \<3 months prior to enrollment

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Erasmus Medical Center

Rotterdam, South Holland, 3015 GD, Netherlands

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Sing-Chien Yap
• Organization: Erasmus MC

s.c.yap@erasmusmc.nl

+31650031551

Study Officials

• Sing-Chien Yap, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiologist-electrophysiologist

Model Details: Prospective, single-arm, single-center, study

Study Record Dates

• First Submitted: May 21, 2023
• First Posted: May 31, 2023
• Study Start: October 2, 2023
• Primary Completion: April 29, 2024
• Study Completion: April 23, 2025
• Last Updated: December 4, 2025
• Results First Posted: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)