NCT07456540

Comparison of Available Standard Pulse Field Ablation Methods for Pulmonary Vein Isolation for Treatment of Atrial Fibrillation

Comparison of Available Standard Methods for Pulmonary Vein Isolation for Ablation Treatment of Atrial Fibrillation

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,125 (estimated)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this cluster randomization study is to evaluate currently used standard methods for pulse field ablation in patients with irregular heart rhythm also called atrial fibrillation (AF) who are treated at Rigshospitalet and Gentofte Hospital in Copenhagen, Denmark. A cluster randomization study tests standardized treatments by rotating the treatments over time periods. All patients will be treated with the specific standard treatment of the period and will be informed about the study. The patient will have the option to decline their participatiion in the study in writing and their data will not be collected. The main purpose of the study is to investigate whether one of more of the systems are more efficient in preventing AF or atrial flutter during the following 12 months. Additionally, the safety of the systems are compared to see if one or more are more efficient in preventing complications 30 days after the ablation procedure. The patients will receive standard treatment according to the cluster at the time of their ablation and data for up to 12 months post procedure will be collected by medicial chart review.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Pulse field ablation Systems	Pulse field ablation Systems

Timeline

• Start date: 2026-02-15
• Primary completion: 2030-04-30
• Completion: 2030-04-30
• First posted: 2026-03-06
• Last updated: 2026-03-06

Locations

1 site across 1 country: Denmark