EUropean Real World Outcomes With Pulsed Field AblatiOn

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardioangiologisches Centrum Bethanien

Frankfurt am Main, 60431, Germany

About this study

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.

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.
Description of the incidence of major adverse cardiovascular events (MACE) during or after the ablation.
Evolution of procedural metrics (procedure time, fluoroscopy time, safety) during the adoption of the technology across different centers and operators.
Comparison of different workflows for the PFA ablation procedure and the effects on outcomes.
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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All patients who underwent an AF catheter ablation procedure using the FARAPULSE PFA system until 31.05.2022

Exclusion criteria

None

Treatment and study plan

Catheter ablation

Device

Catheter Ablation of Atrial Fibrillation

Primary outcomes

Arrhythmia Free Survival

Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Cardioangiologisches Centrum Bethanien

Other

Registry information

Official study title

EUropean Real World Outcomes With Pulsed Field AblatiOn in Patients With Symptomatic AtRIAl Fibrillation

Acronym: EU-PORIA

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Apr 21, 2023
Registry last updated: Nov 14, 2023

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.

Published trials that share one or more normalized conditions with this study.

Completed