Atrial FibrillationEU-PORIANCT05823818
EUropean Real World Outcomes With Pulsed Field AblatiOn
An observational study of Atrial Fibrillation, run by Cardioangiologisches Centrum Bethanien at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Catheter Ablation
- Type of treatment
- Medical device
- How many people
- 1,233 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2021to 31 May 2023
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Symptomatic Atrial Fibrillation
Who may be able to join
- All patients who underwent an AF catheter ablation procedure using the FARAPULSE PFA system until 31.05.2022
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Catheter Ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter AblationDevice
Catheter Ablation of Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Arrhythmia Free Survival
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start1 Mar 2021
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,233 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Cardioangiologisches Centrum Bethanien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05823818
- Sponsor's protocol ID
- 20230001
- Acronym
- EU-PORIA
- Status last verified
- Apr 2023
- First submitted
- 10 Apr 2023
- Last updated
- 14 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 39601122Kueffer T, Bordignon S, Neven K, Blaauw Y, Hansen J, Adelino R, Ouss A, Futing A, Roten L, Mulder BA, Ruwald MH, Mene R, van der Voort P, Reinsch N, Boveda S, Albrecht EM, Schneider CW, Chun KRJ, Schmidt B, Reichlin T. Durability of Pulmonary Vein Isolation Using Pulsed-Field Ablation: Results From the Multicenter EU-PORIA Registry. JACC Clin Electrophysiol. 2024 Apr;10(4):698-708. doi: 10.1016/j.jacep.2023.11.026. Epub 2024 Feb 7.
PubMed 38340118
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EUropean Real World Outcomes With Pulsed Field AblatiOn in Patients With Symptomatic AtRIAl Fibrillation
- ClinicalTrials.gov ID
- NCT05823818
- Acronym / sponsor ID
- EU-PORIA / 20230001
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,233 participants (actual)
- Lead sponsor
- Cardioangiologisches Centrum BethanienUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 21 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Symptomatic Atrial Fibrillation
Key inclusion criteria (1 listed)
- All patients who underwent an AF catheter ablation procedure using the FARAPULSE PFA system until 31.05.2022
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Catheter AblationCatheter Ablation of Atrial Fibrillation | Device | – |
Primary outcome
Arrhythmia Free Survival
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Derived from this study: PubMed 39601122Futing 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.
- Derived from this study: PubMed 38340118Kueffer T, Bordignon S, Neven K, Blaauw Y, Hansen J, Adelino R, Ouss A, Futing A, Roten L, Mulder BA, Ruwald MH, Mene R, van der Voort P, Reinsch N, Boveda S, Albrecht EM, Schneider CW, Chun KRJ, Schmidt B, Reichlin T. Durability of Pulmonary Vein Isolation Using Pulsed-Field Ablation: Results From the Multicenter EU-PORIA Registry. JACC Clin Electrophysiol. 2024 Apr;10(4):698-708. doi: 10.1016/j.jacep.2023.11.026. Epub 2024 Feb 7.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Cardioangiologisches Centrum Bethanien at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arrhythmia Free Survival (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05823818, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.