EUropean Real World Outcomes With Pulsed Field AblatiOn
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Observational [Patient Registry]

Summary: 
      Background: Real world clinical evidence using pulsed field ablation (PFA) for atrial
      fibrillation (AF) ablation is still scarce. In particular, data on longer term outcome from
      multi-center experience is missing.

      Aim: To describe real-world adaption, work-flow data as well as procedural and follow-up
      outcomes after PFA guided AF ablation in early European users.

      Methods: A multi-center registry, European real-world outcomes with Pulsed Field Ablation in
      Patients with Symptomatic AF - EU-PORIA - was designed.

      All-comer data of patients with symptomatic atrial fibrillation (AF) who underwent catheter
      ablation using PFA will be collected from 7 European high-volume centers who were involved in
      the early market release of the FARAPULSE technology. Data includes patient demographics,
      procedural metrics on safety and efficacy as well as follow-up outcome data. Learning curve
      characteristics and comparison on different workflows will be assessed.
    

Detailed description: 
      Design A retrospective multi center registry will be conducted assessing European Real World
      Outcomes with Pulsed Field Ablation in Patients with Symptomatic Atrial Fibrillation
      (EU-PORIA registry). In total, seven high volume PFA centers from Europe will collect data on
      center characteristics, demographic patient information, procedural metrics, safety and
      efficacy parameters as well as 12 months clinical outcome with regards to freedom from atrial
      tachyarrhythmia and major adverse cardiovascular events (MACE).

      Inclusion criteria All patients who underwent an AF catheter ablation procedure using the
      FARAPULSE PFA system until 31.05.2022 will be included into the analysis.

      Endpoints The analysis will focus on variable endpoints.

        1. Assessment of 6 months and 12 months clinical success rate defined as freedom from use
           of any Type I or Type III antiarrhythmic medication for the treatment of AF, AFL, or AT
           after the blanking period.

        2. Description of the incidence of major adverse cardiovascular events (MACE) during or
           after the ablation.

        3. Evolution of procedural metrics (procedure time, fluoroscopy time, safety) during the
           adoption of the technology across different centers and operators.

        4. Comparison of different workflows for the PFA ablation procedure and the effects on
           outcomes.

        5. Analysis of repeat ablation procedures after an index PFA ablation with focus on lesion
           durability and type of arrhythmia recurrence.

      Number of Patients It is expected that up to 1500 patients from 7 European centers will enter
      the registry.

      Timeline This is a retrospective study. Data of above defined patients will be collected
      until January 15th. After database cleaning and plausibility checks statistical analysis will
      be carried out. To increase the number of patients with 12 M follow-up, another data-update
      will be performed end of May 2023.

      Statistical analysis Descriptive and comparative analyses will be performed using appropriate
      statistical tests. Kaplan Meier arrhythmia free survival curves using logistic regression
      analysis will be computed.
    

Intervention name(s): Catheter Ablation
Intervention type(s): Device
Intervention description(s): Catheter Ablation of Atrial Fibrillation
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Symptomatic Atrial Fibrillation