Atrial fibrillation
Conditions
Interventions
We will assess the effectiveness in achieving durable PVI with the VariPulse catheter. 
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: History of symptomatic paroxysmal AFSubjects who are indicated for a PVI according to the 2020 ESC guidelines for the diagnosis and management of AFSubjects who are willing and capable of undergoing a mandatory repeat procedure 2-3 months after the index procedureSubjects whose age is 18-80 yearsSubjects who are willing and capable of providing informed consent
Exclusion criteria
Exclusion criteria: Any known contraindication to an atrial fibrillation ablation or anticoagulationHistory of previous LA ablation or surgical treatment of atrial fibrillation, atrial flutter, or atrial tachycardiaAtrial fibrillation secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac causeSignificant structural heart diseaseHistory of blood clotting or bleeding diseaseSevere kidney disease (glomerular filtration rate <30 ml/min/1.73 m2)Stroke or transient ischemic attack <3 months prior to enrollmentActive systemic infectionPregnant, lactating, or women of childbearing potential who are, or plan to become, pregnant during the time of the studySubjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the incidence of PV reconnection at the repeat procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome include the area of low voltage in the left atrium at the repeat procedure. | — |
Countries
Netherlands
Contacts
Public ContactS.C. Yap
Erasmus MC, Universitair Medisch Centrum Rotterdam
Outcome results
None listed