Early Recurrences of Atrial Arrhythmias and Their Impact on Late Recurrence After Pulmonary Vein Isolation With Pulsed Field Ablation of Paroxysmal Atrial Fibrillation

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

This is a prospective, single-arm study conducted in University Hospital of Split, Department of Cardiology. Patients treated with PFA for symptomatic paroxysmal atrial fibrillation will be asked to participate in the study. An implantable loop recorder (ILR) will be placed immediately after the PFA procedure for rhythm monitoring. Early recurrences will be subsequently divided into very early recurrences (up to 1 month post-procedure) and early recurrences (1-3 months post-procedure). Late recurrences will be defined as those 3 to 12 months post-procedure. Patients will be monitored routinely through follow up visits during which ILR will be interrogated and eventual symptoms will be assessed. Follow-up visits will be scheduled 1, 3, 6, 12 months post-procedure. Median follow-up will be 12 months. Data for the study will be obtained from a loop monitor to assess the arrhythmia burden during follow-up visits in the University Hospital of Split Arrhythmia Clinic.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
View:

• Age \>18

• Index PFA procedure after one failed or intolerant group I or III of the antiarrhythmic drug in patients with symptomatic paroxysmal AF (AF with self-terminating episodes lasting no longer than 7 continuous days)

• Willing and able to provide informed consent.

Locations
Other Locations
Croatia
University Hospital Center Split
RECRUITING
Split
Contact Information
Primary
Lucija Lisica, MD
lucijalisica21@gmail.com
+385995094697
Backup
Zrinka Jurišić, Ass. Prof., MD
zrinkacn@gmail.com
+385915262844
Time Frame
Start Date: 2021-11-17
Estimated Completion Date: 2024-05-17
Participants
Target number of participants: 40
Treatments
ERAF after PFA
Patients with an early recurrence after pulsed field ablation of paroxysmal atrial fibrillation.
no ERAF after PFA
Patients without an early recurrence after pulsed field ablation of paroxysmal atrial fibrillation.
Related Therapeutic Areas
Sponsors
Leads: University of Split, School of Medicine

This content was sourced from clinicaltrials.gov