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

Launched by UNIVERSITY OF SPLIT, SCHOOL OF MEDICINE · Apr 7, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how early episodes of irregular heartbeats, called atrial fibrillation (AF), after a specific heart procedure known as pulsed field ablation (PFA) can affect the chances of having more episodes later on. The trial is taking place at the University Hospital of Split and involves patients who have experienced symptomatic paroxysmal atrial fibrillation, which means their AF comes and goes but is bothersome. Participants will have a small device called an implantable loop recorder placed in their body after the PFA to monitor their heart rhythm. The study will follow patients over a year to see how often they experience these irregular heartbeats and if early episodes lead to more problems later.

To be eligible for the trial, patients must be over 18 years old and have had a prior unsuccessful attempt to manage their AF with medication. However, those with certain health issues, such as a history of heart surgery, other medical conditions causing AF, or those who are pregnant or breastfeeding, will not be included. Participants can expect regular follow-up visits at 1, 3, 6, and 12 months after their treatment, where their heart rhythm will be checked, and any symptoms will be discussed. This study aims to improve the understanding of AF management and help doctors provide better care for patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • Any known contraindication to AF ablation or anticoagulation.
• • History of previous left atrial ablation or surgical treatment.
• • Secondary AF due to reversible or non-cardiac cause such as thyroid disease and electrolyte imbalance.
• • Asymptomatic AF patients, persistent AF, permanent AF patients.
• • History of clotting or bleeding disease or cryoglobulinemia.
• • Pregnant or lactating.
• • Other conditions that may make the patient a poor candidate for procedure such as mental illness, terminal illness, vulnerable patient population.