EUropean Real World Outcomes With Pulsed Field AblatiOn (EU-PORIA)

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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Catheter Ablation

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.

• Study Type: Observational
• Enrollment (Actual): 1233

Contacts and Locations

Study Locations

• Germany
  • Frankfurt/Main, Germany, 60431
    • Cardioangiologisches Centrum Bethanien

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Symptomatic Atrial Fibrillation

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Arrhythmia Free Survival	12 months

Collaborators and Investigators

• Sponsor: Cardioangiologisches Centrum Bethanien

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: April 10, 2023
• First Submitted That Met QC Criteria: April 10, 2023
• First Posted (Actual): April 21, 2023

Study Record Updates

• Last Update Posted (Actual): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 20230001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes