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

NCT ID: NCT05881733

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-02
• Study Completion Date: 2025-04-23

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.

Detailed Description

Rationale: The next generation POLARx cryoablation balloon (CB) catheter will have the option of to deliver cryotherapy with the current balloon size of 28 mm or a new, larger 31 mm size by changing the inner balloon pressure (POLARx FIT, Boston Scientific). Currently, there is no data on the extension of left atrial (LA) lesion formation with the 31 mm balloon size of the POLARx FIT cryoablation balloon catheter. The hypothesis is that a larger CB size results in a wide antral circumferential lesion.

Objective: The primary objective is to evaluate the antral lesion size using ultrahigh-density (UHDx) mapping pre- and post-cryoablation with the 31 mm balloon size CB. Secondary objectives are the proportion of pulmonary veins (PVs) where a 31 mm CB could be positioned to achieve a grade 4 occlusion and the single shot success rate with the 31 mm balloon size CB.

Study design: Single-center, single-arm, prospective study with pre- and post-PVI UHDx mapping.

Study population: Twenty adult patients with paroxysmal AF who are scheduled to undergo pulmonary vein isolation (PVI) with a CB.

Intervention: Patients will undergo pre- and post-ablation UHDx mapping (Orion catheter and Rhythmia 3D-mapping system, Boston Scientific) during the index procedure.

Main study parameters/endpoints: The primary endpoint is the extent of the antral lesion size. Secondary endpoints are the proportion of PVs with grade 4 occlusion with the 31 mm balloon size CB, the single shot success rate of the 31 mm balloon size CB, difference in rate of achieving grade 4 occlusion in comparison to the standard (28 mm) size.

Nature and extent of the burden and risks associated with participation, benefit, and group relatedness: A UHDx mapping will be acquired before and after complete PVI. The procedures will be performed under deep sedation, which is standard practice for CB procedures in our institution. The risk of additional mapping is limited. LA mapping is a standard diagnostic method for patients undergoing PVI with radiofrequency ("standard-of-care"). In the current study, UHDx mapping will now be used in patients undergoing PVI with CB. The most important complication of additional intracardiac mapping is cardiac tamponade, but this risk is low (<0.5%).

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

POLARx FIT cryoballoon

Intervention Type: DEVICE

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

Interventions

POLARx FIT cryoballoon

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. History of symptomatic paroxysmal AF

2. Subjects who are indicated for a PVI according to the 2020 ESC guidelines for the diagnosis and management of AF

3. Subjects who are willing and capable of providing informed consent

4. Subjects who are willing and capable of participating in all testing associated with this clinical investigation

5. Subjects whose age is 18 years or above

Exclusion Criteria

1. Any known contraindication to an AF ablation or anticoagulation

2. History of previous left atrial ablation or surgical treatment of AF, atrial flutter, or atrial tachycardia

3. AF secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause

4. Significant structural heart disease as evidenced by:

1. Left ventricular ejection fraction <45% based on most recent transthoracic echocardiogram (TTE) performed <6 months prior to enrollment

2. LA diameter >55 mm based on most recent TTE performed <6 months prior to enrollment

3. Previous cardiac surgery

4. Previous cardiac valvular surgical or percutaneous procedure

5. Interatrial baffle, closure device, patch, or occluder

6. Unstable angina or ongoing myocardial ischemia

7. Moderate or severe valvular heart disease on most recent TTE performed <6 months prior to enrolment

8. Congenital heart disease

9. Left atrial thrombus

5. History of blood clotting or bleeding disease

6. Stroke or transient ischemic attack <3 months prior to enrollment

7. Active systemic infection

8. Common ostium PV >24 mm defined by CT-scan

9. Pregnant, lactating, or women of childbearing potential who are, or plan to become, pregnant during the time of the study

10. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: collaborator

Erasmus Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sing-Chien Yap, MD, PhD

Cardiologist-electrophysiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sing-Chien Yap, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

Erasmus Medical Center

Rotterdam, South Holland, Netherlands

Countries

Netherlands

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NL84423.078.23

Identifier Type: REGISTRY

Identifier Source: secondary_id

MEC-2023-0325

Identifier Type: -

Identifier Source: org_study_id