Atrial Fibrillation
Conditions
Keywords
Atrial Fibrillation, AF, Ablation, pulmonary vein isolation, PVI
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.
Interventions
DEVICEPulse field ablation Systems
Pulse field ablation Systems
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older * Planned Catheter Ablation of Atrial Fibrillation with Pulmonary Vein Isolation
Exclusion criteria
\- Opt out of data collection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Atrial fibrillation or atrial flutter | 12 months post procedure | Relapse atrial fibrillation or flutter meassured remote (Loop or watch) or in clinic (EKG) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization due to atrial fibrillation or flutter | 12 months post procedure | Hospitalization due to atrial fibrillation or flutter including DC cardioversion |
| Patient reported outcome measures | 12 month | Patient reported symptoms and quality of life (Questionnaires) |
| Patient reported outcomes measures | 6 month | Patient reported symptoms and quality of life (Questionnaires) |
| Antiarrhythmic medications | 12 months post procedure | Use of antiarrhythmic medications |
| Duration of the procedure | Post procedure | The duration of the ablation procedure |
| Safety of the system | 30 days post procedure | The frequency of procedure-related complications |
Countries
Denmark
Contacts
CONTACTPeter K Jacobsen, MD, DMSc
PRINCIPAL_INVESTIGATORPeter K Jacobsen, MD, PhD
Rigshospitalet, Denmark
Outcome results
None listed