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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,125
Pulse field ablation Systems
Rigshospitalet
Copenhagen, Denmark
Atrial fibrillation or atrial flutter
Relapse atrial fibrillation or flutter meassured remote (Loop or watch) or in clinic (EKG)
Time frame: 12 months post procedure
Atrial fibrillation or atrial flutter
Relapse atrial fibrillation or flutter meassured remote (Loop or watch) or in clinic (EKG)
Time frame: 6 months post procedure
Atrial fibrillation or atrial flutter
Relapse atrial fibrillation or flutter meassured remote (Loop or watch) or in clinic (EKG)
Time frame: 3 months post procedure
Hospitalization due to atrial fibrillation or flutter
Hospitalization due to atrial fibrillation or flutter including DC cardioversion
Time frame: 12 months post procedure
Hospitalization due to atrial fibrillation or flutter
Hospitalization due to atrial fibrillation or flutter including DC cardioversion
Time frame: 6 months post procedure
Patient reported outcome measures
Patient reported symptoms and quality of life (Questionnaires)
Time frame: 12 month
Patient reported outcomes measures
Patient reported symptoms and quality of life (Questionnaires)
Time frame: 6 month
Patient reported outcomes measures
Patient reported symptoms and quality of life (Questionnaires)
Time frame: 3 month
Antiarrhythmic medications
Use of antiarrhythmic medications
Time frame: 12 months post procedure
Antiarrhythmic medications
Use of antiarrhythmic medications
Time frame: 6 months post procedure
Duration of the procedure
The duration of the ablation procedure
Time frame: Post procedure
Safety of the system
The frequency of procedure-related complications
Time frame: 30 days post procedure
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