Electroporation for Treatment of Atrial Fibrillation

Launched by UNIVERSITY MEDICAL CENTRE LJUBLJANA · Nov 13, 2023

Keywords

ClinConnect Summary

This study is comparing two ways to treat persistent atrial fibrillation (AF): radiofrequency ablation (RF) and pulse field ablation (electroporation). Both approaches aim to isolate tissue around the pulmonary veins and a part of the left atrium to help prevent AF from coming back. Participants are randomly assigned to one of the two treatments, and both patients and doctors know which treatment is being given. The main goal is to see how durable the electrical isolation is after about 3 months, using a detailed heart mapping test. Researchers will also look at whether patients stay free from AF over 12 months and how safe the procedures are, including checks for esophageal injury and any complications within 30 days.

To join, adults aged 18 to 80 with persistent or longstanding persistent AF must have AF documented on heart tests on two separate occasions at least a week apart, and they should not have had a prior catheter ablation or heart surgery. Other criteria include a reasonable life expectancy and no serious acute illness or blood clots. The study plans to enroll up to about 50 people at one center in Ljubljana, Slovenia (University Medical Centre Ljubljana). If eligible, participants will have CT imaging and 3D heart mapping before the procedure, a follow-up 3 months later to check durability, and ongoing heart monitoring at 3, 6, and 12 months. The study began in 2023 and is currently enrolling by invitation, with an expected completion around 2027.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • atrial fibrillation recorded with 12-lead ECG, holter ECG or implantable device on two occasions at least one week apart
• Exclusion Criteria:
• • history of previous catheter ablation, history of previous heart surgery, life expectancy less than one year, any lifethreatening severe acute condition, acute deep venous thrombosis, presence of intracardiac masses or thrombi.