NCT05881733Completed
Effect of a Bigger Cryoballoon on the Total Antral Lesion Size: Evaluation of POLARx FIT
Source: ClinicalTrials.gov · Last updated 4 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 21 May 2023
- Start date
- 2 Oct 2023
- Primary completion date
- 29 Apr 2024
- Lead sponsor
- Erasmus Medical Center
- Diseases
- Atrial fibrillation
- NCT number
- NCT05881733
What you commit to
- Study type: Interventional
- Participants enrolled: 20
- From 2 Oct 2023 to the primary completion date, 29 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of previous left atrial ablation or surgical treatment of AF, atrial flutter, or atrial tachycardia
- Stroke or transient ischemic attack \<3 months prior to enrollment
Other illness
- AF secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause
- History of blood clotting or bleeding disease
- Active systemic infection
Lab values
- 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
Other
- Any known contraindication to an AF ablation or anticoagulation
- Common ostium PV \>24 mm defined by CT-scan
- Pregnant, lactating, or women of childbearing potential who are, or plan to become, pregnant during the time of the study
- Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Erasmus Medical Center Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.