Ignite Creation Date:
2024-05-06 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05823818
Status:
COMPLETED
Last Update Posted:
2023-11-14
First Post:
2023-04-10
Brief Title:
EUropean Real World Outcomes With Pulsed Field AblatiOn
Sponsor:
Cardioangiologisches Centrum Bethanien
Organization:
Cardioangiologisches Centrum Bethanien
Study Overview
Official Title:
EUropean Real World Outcomes With Pulsed Field AblatiOn in Patients With Symptomatic AtRIAl Fibrillation
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EU-PORIA
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
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 31052022 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
Inclusion criteria All patients who underwent an AF catheter ablation procedure using the FARAPULSE PFA system until 31052022 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None