Rigshospitalet
Copenhagen, 2100, Denmark
NCT Number: NCT07456540
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 opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Copenhagen, 2100, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pulse field ablation Systems
Time frame: 12 months post procedure
Relapse atrial fibrillation or flutter meassured remote (Loop or watch) or in clinic (EKG)
Time frame: 6 months post procedure
Relapse atrial fibrillation or flutter meassured remote (Loop or watch) or in clinic (EKG)
Time frame: 3 months post procedure
Relapse atrial fibrillation or flutter meassured remote (Loop or watch) or in clinic (EKG)
Time frame: 12 months post procedure
Hospitalization due to atrial fibrillation or flutter including DC cardioversion
Time frame: 6 months post procedure
Hospitalization due to atrial fibrillation or flutter including DC cardioversion
Time frame: 12 month
Patient reported symptoms and quality of life (Questionnaires)
Time frame: 6 month
Patient reported symptoms and quality of life (Questionnaires)
Time frame: 3 month
Patient reported symptoms and quality of life (Questionnaires)
Time frame: 12 months post procedure
Use of antiarrhythmic medications
Time frame: 6 months post procedure
Use of antiarrhythmic medications
Time frame: Post procedure
The duration of the ablation procedure
Time frame: 30 days post procedure
The frequency of procedure-related complications
Time frame: 12 month
Total costs of treatment (Hospitalization, DC-conversiton, medication and procedure-related costs) in Euros
Contact information is provided by the study sponsor or research team.
Rigshospitalet, Denmark
Other
Comparison of Available Standard Methods for Pulmonary Vein Isolation for Ablation Treatment of Atrial Fibrillation
Acronym: PVI-MODE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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