Radiofrequency Balloon Ablation for Atrial Fibrillation: Durability of Pulmonary Vein Isolated and Clinical Outome - Trial NCT06296888

Timeline & Enrollment

Primary Outcome

Proportion of durably isolated PVs observed at repeat EP study

Summary

Atrial fibrillation (AF) is the most common heart rhythm disorder affecting 2-4% of the adult
 human population. AF is a disturbance in the electrical impulses of the heart - an electrical
 disturbance commonly originating from the pulmonary veins.
 
 Normalization of the heart rhythm with anti-arrhythmic drugs often fail and is frequently
 associated with side effects. Therefore, a treatment termed ablation by catheters via an
 inguinal vein has been devised and is increasingly being used for the treatment of AF. The
 cornerstone of this treatment is electrical isolation of the pulmonary veins so that the
 nocuous electrical impulses from the pulmonary veins cannot cause a disturbance in the heart
 rhythm and initiate episodes of AF. This treatment is called pulmonary vein isolation (PVI).
 Recent studies have shown that PVI is better than anti-arrhythmic drug treatment in the
 prevention of recurrence of AF, but despite substantial improvements in techniques and tools
 only 60-70% are cured from AF by a single PVI procedure, and in around 80% of patients who
 require additional catheter ablation, durable isolation of all the pulmonary veins has not
 been achieved. Improved tools for durable PVI are therefore required.
 
 A novel catheter to achieve PVI called the HELIOSTAR™ radiofrequency balloon ablation
 catheter has shown promising clinical results with a favorable safety profile, but the
 durability of PVI has not been evaluated. Therefore, we aim to investigate the long-term
 durability of PVI by the radiofrequency balloon and the clinical outcome following the
 procedure.
 
 In this study, patients with AF referred for catheter ablation will undergo an initial PVI
 treatment using the radiofrequency balloon catheter. All patients will undergo a repeat
 electrophysiology (EP) study after 4-6 months to determine to durability of PVI. Patients
 will be issued with a 48-hour heart rhythm monitor at 3 and 12 months after the initial PVI.
 Patients-reported effects on quality of life by AF related symptoms will be evaluated using a
 specialized questionnaire provided approximately every third month throughout the 12 month
 follow-up.

ICD-10 Classifications