Effect of a bigger cryoballoon on the total antral lesion size: Evaluation of POLARx FIT
- Conditions
- Atrial fibrillationirregular heart beat10007521
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 20
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
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 noncardiac cause
4. Significant structural heart disease
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
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is the extent of the antral lesion size. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints are the proportion of PVs with grade 4 occlusion with the<br /><br>31 mm balloon size CB, the single shot success rate of the 31 mm balloon size<br /><br>CB, difference in rate of achieving grade 4 occlusion in comparison to the<br /><br>standard (28 mm) size.</p><br>