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

NCT05328882 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2023-10-06

No results posted yet for this study

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.

Conditions

  • Atrial Fibrillation Paroxysmal
  • Recurrence

Interventions

OTHER

Monitoring of paroxysmal atrial fibrillation recurrence after pulsed field catheter ablation

The implanted loop recorder will be interrogated to see how many patients had an early recurrence of AF (up to 3 months after the procedure). Then the late recurrence rate will be compared (3-12 months post-procedure) between groups with and without early recurrences.

Sponsors & Collaborators

  • University of Split, School of Medicine

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-17
Primary Completion
2024-05-17
Completion
2024-05-17
FDA Device
Yes

Countries

  • Croatia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05328882 on ClinicalTrials.gov