EUropean Real World Outcomes With Pulsed Field AblatiOn
EU-PORIA
1 other identifier
observational
1,233
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2021
CompletedFirst Submitted
Initial submission to the registry
April 10, 2023
CompletedFirst Posted
Study publicly available on registry
April 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2023
CompletedNovember 14, 2023
April 1, 2023
2.2 years
April 10, 2023
November 13, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Arrhythmia Free Survival
12 months
Interventions
Catheter Ablation of Atrial Fibrillation
Eligibility Criteria
Symptomatic Atrial Fibrillation
You may qualify if:
- All patients who underwent an AF catheter ablation procedure using the FARAPULSE PFA system until 31.05.2022
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cardioangiologisches Centrum Bethanien
Frankfurt am Main, 60431, Germany
Related Publications (1)
Futing A, Neven K, Bordignon S, Reichlin T, Blaauw Y, Hansen J, Adelino R, Ouss A, Roten L, Mulder BA, Ruwald MH, Mene R, van der Voort P, Reinsch N, Kueffer T, Boveda S, Albrecht EM, Raybuck JD, Sutton B, Chun KRJ, Schmidt B. Pulsed Field Ablation as First-Line Therapy for Atrial Fibrillation: A Substudy of the EU-PORIA Registry. Circ Arrhythm Electrophysiol. 2024 Dec;17(12):e013088. doi: 10.1161/CIRCEP.124.013088. Epub 2024 Nov 27.
PMID: 39601122DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 24 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2023
First Posted
April 21, 2023
Study Start
March 1, 2021
Primary Completion
May 31, 2023
Study Completion
May 31, 2023
Last Updated
November 14, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share