Comparison of Available Standard Pulse Field Ablation Methods for Pulmonary Vein Isolation for Treatment of Atrial Fibrillation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pulse field ablation Systems.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Available Standard Methods for Pulmonary Vein Isolation for Ablation Treatment of Atrial Fibrillation
Overview
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
- Device Pulse field ablation Systems
Pulse field ablation Systems
Primary outcome measures
- Atrial fibrillation or atrial flutter [Time frame: 12 months post procedure]
- Atrial fibrillation or atrial flutter [Time frame: 6 months post procedure]
- Atrial fibrillation or atrial flutter [Time frame: 3 months post procedure]
Secondary outcome measures (9)
- Hospitalization due to atrial fibrillation or flutter [Time frame: 12 months post procedure]
- Hospitalization due to atrial fibrillation or flutter [Time frame: 6 months post procedure]
- Patient reported outcome measures [Time frame: 12 month]
- Patient reported outcomes measures [Time frame: 6 month]
- Patient reported outcomes measures [Time frame: 3 month]
- Antiarrhythmic medications [Time frame: 12 months post procedure]
- Antiarrhythmic medications [Time frame: 6 months post procedure]
- Duration of the procedure [Time frame: Post procedure]
- Safety of the system [Time frame: 30 days post procedure]
Eligibility criteria
Inclusion criteria
- 18 years or older
- Planned Catheter Ablation of Atrial Fibrillation with Pulmonary Vein Isolation
Exclusion criteria
\- Opt out of data collection
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Rigshospitalet — Copenhagen
Identifiers
NCT: NCT07456540 · PVI-MODE