Brief 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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,125

participants targeted

Target at P75+ for not_applicable atrial-fibrillation

Timeline

48mo left

Started Feb 2026

Typical duration for not_applicable atrial-fibrillation

Geographic Reach

1 country

1 active site

Status

not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.2 years study duration

Study Progress6%

Feb 2026Apr 2030

First Submitted

Initial submission to the registry

January 26, 2026

Completed

20 days until next milestone

Study Start

First participant enrolled

February 15, 2026

Completed

19 days until next milestone

First Posted

Study publicly available on registry

March 6, 2026

Completed

4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2030

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2030

Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

4.2 years

First QC Date

January 26, 2026

Last Update Submit

March 3, 2026

Conditions

Atrial Fibrillation

Keywords

Atrial FibrillationAFAblationpulmonary vein isolationPVI

Outcome Measures

Primary Outcomes (3)

Atrial fibrillation or atrial flutter
Relapse atrial fibrillation or flutter meassured remote (Loop or watch) or in clinic (EKG)
12 months post procedure
Atrial fibrillation or atrial flutter
Relapse atrial fibrillation or flutter meassured remote (Loop or watch) or in clinic (EKG)
6 months post procedure
Atrial fibrillation or atrial flutter
Relapse atrial fibrillation or flutter meassured remote (Loop or watch) or in clinic (EKG)
3 months post procedure

Secondary Outcomes (9)

Hospitalization due to atrial fibrillation or flutter
12 months post procedure
Hospitalization due to atrial fibrillation or flutter
6 months post procedure
Patient reported outcome measures
12 month
Patient reported outcomes measures
6 month
Patient reported outcomes measures
3 month
+4 more secondary outcomes

Other Outcomes (1)

Resources and costs
12 month