Persistent Atrial FibrillationELECTROAFNCT06134752
Electroporation for Treatment of Atrial Fibrillation
A study testing Pulse field ablation and Radiofrequency ablation in people with Persistent Atrial Fibrillation and Longstanding Persistent Atrial Fibrillation, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
Comparison of pulmonary vein and left atrial posterior wall isolation durability and clinical outcome between radiofrequency and pulse field ablation in patients with persistent and longstanding persistent atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation
- What is being tested?
- Pulse field ablation and Radiofrequency ablation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSlovenia
- Study dates
- 5 Dec 2023to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- atrial fibrillation recorded with 12-lead ECG, holter ECG or implantable device on two occasions at least one week apart
Who cannot join
- history of previous catheter ablation, history of previous heart surgery, life expectancy less than one year, any lifethreatening severe acute condition, acute deep venous thrombosis, presence of intracardiac masses or thrombi.
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
Cardiovascular Surgery Department, University Medical Centre Ljubljana
Ljubljana, 1000
About this study
Official title: Electroporation for Treatment of Persistent and Longstanding Persistent Atrial Fibrillation
Comparison of pulmonary vein and left atrial posterior wall isolation durability and clinical outcome between radiofrequency and pulse field ablation in patients with persistent and longstanding persistent atrial fibrillation.
Read the detailed description
Patients with persistent and longstanding persistent atrial fibrillation will be randomized to control and investigational group.
In control group they will receive pulmonary vein and posterior wall ("box lesion") isolation with point by point radiofrequency ablation utilizing the CLOSE protocol with predetermined interlesion distance of up to 6 mm and predetermined ablation index/lesion size index.
In investigational group they will receive pulmonary vein and posterior wall ("box lesion" and additional ablations inside the "box") isolation with point by point pulse field ablation with a predetermined interlesion distance of up to 6 mm and predetermined energy delivery settings.
30 minutes after the last ablation point a high-density mapping of the left atrium will be performed.
Preprocedurally all patients will undergo computer tomography angiography of the left atrium, which will be processed resulting in a three dimensional anatomy reconstruction that will be utilized during the procedures in conjunction with the three dimensional mapping system. Also, left atrial wall thickness will be determined and displayed on the three dimensional anatomy reconstruction.
Before and after radiofrequency and pulse field ablation a five minute bipolar and unipolar intracardiac electrogram recording will be performed at at least two predetermined locations according to wall thickness (at the thinest and at the thickest part of the wall) for later analysis of changes due to different modes of ablation with correlation to lesion durability at a three month re-mapping procedure.
Collection of full blood before and 24 and 48 hours after the procedure to analyse activation of inflammation, coagulation, and also nevral tissue injury and endotelial injury due to ablation. Deviation of markers from the baseline value before the procedure will serve as a measure of activation. Markers analysed: troponin (ng/ml), D dimer (mg/l fibrinogen equivalent units), protein S100 (ng/ml), protein NSE (ng/ml), NT proBNP (pg/ml), high sensitivity CRP (mg/l), interleukin (IL) 6 (pg/ml), procalcitonin (ng/ml), fibrinogen (g/l), P selectin /pg/ml).
Postprocedurally pateints will undergo a remapping procedure three months later to determine pulmonary vein and left atrial posterior wall isolation durability.
Pateints will be followed up with clinical checkup and 1-7 day ECG holters at 3, 6, 12 months.
- Being tested
- Pulse field ablation, Radiofrequency ablation
- Keywords
- persistent atrial fibrillation, pulse field ablation, radiofrequency 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.
Pulse field ablationOther
Point by point isolation of pulmonary veins and left atrial posterior wall
Radiofrequency ablationOther
Point by point isolation of pulmonary veins and left atrial posterior wall
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency ablation | Active comparator | Pulmonary vein and left atrial posterior wall isolation with point by point radiofrequency ablation. Receives: Other: Radiofrequency ablation |
| Pulse field ablation | Experimental | Pulmonary vein and left atrial posterior wall isolation with point by point pulse field ablation. Receives: Other: Pulse field ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Durability of isolation
Testing for durability of pulmonary vein and left atrial posterior wall isolation in both study arms with high density endocardial remapping.
Absence of electrical activity or voltage inside ablation lines of less than 0.05 mV or presence of exit block upon pacing with local capture will be considered as proof of pulmonary vein and posterior left atrial wall isolation.
Measured: 3 months
Secondary outcomes (3)
Freedom from atrial arrhythmias
Freedom from atrial tachycardia, atrial flutter and atrial fibrillation during the follow up as assessed with 12-lead ECG and 1-7 day holter ECG recordings at 3, 6, 12 months. With holter recordings any arrhythmia lasting at least 30 seconds will be considered as a recurrence.
Measured: 12 months
Intracardiac electrograms analysis
Five minute recording of bipolar and unipolar intracardiac electrograms with a high density mapping catheter at predetermined locations in pulmonary vein antra and left atrial posterior wall before and after radiofrequency and pulse field ablation at the index procedure. Offline analysis of recorded signals and correlation of immediate changes with persistence of durable lesions (isolation) or conduction gaps.
Measured: 1 day
Recording of complications
Postprocedural endoscopy of the esophagus and endoscopic ultrasound of the esophagus up to 72 hours after the procedure for detection of esophageal injury. Recording of any intra and postprocedural complications up to a 30 day period.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start5 Dec 2023
- Primary completion15 Feb 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matevz Jan, University Medical Centre Ljubljana
- Investigators
- Jernej Štublar, BSE, Study chair, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06134752
- Sponsor's protocol ID
- ELECTROAF
- Acronym
- ELECTROAF
- Status last verified
- Feb 2026
- First submitted
- 8 Nov 2023
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroporation for Treatment of Persistent and Longstanding Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT06134752
- Acronym / sponsor ID
- ELECTROAF / ELECTROAF
- Keywords
- persistent atrial fibrillation, pulse field ablation, radiofrequency ablation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 5 Dec 2023 (actual)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 18 Nov 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.
Comparison of pulmonary vein and left atrial posterior wall isolation durability and clinical outcome between radiofrequency and pulse field ablation in patients with persistent and longstanding persistent atrial fibrillation.
Detailed description
Patients with persistent and longstanding persistent atrial fibrillation will be randomized to control and investigational group.
In control group they will receive pulmonary vein and posterior wall ("box lesion") isolation with point by point radiofrequency ablation utilizing the CLOSE protocol with predetermined interlesion distance of up to 6 mm and predetermined ablation index/lesion size index.
In investigational group they will receive pulmonary vein and posterior wall ("box lesion" and additional ablations inside the "box") isolation with point by point pulse field ablation with a predetermined interlesion distance of up to 6 mm and predetermined energy delivery settings.
30 minutes after the last ablation point a high-density mapping of the left atrium will be performed.
Preprocedurally all patients will undergo computer tomography angiography of the left atrium, which will be processed resulting in a three dimensional anatomy reconstruction that will be utilized during the procedures in conjunction with the three dimensional mapping system. Also, left atrial wall thickness will be determined and displayed on the three dimensional anatomy reconstruction.
Before and after radiofrequency and pulse field ablation a five minute bipolar and unipolar intracardiac electrogram recording will be performed at at least two predetermined locations according to wall thickness (at the thinest and at the thickest part of the wall) for later analysis of changes due to different modes of ablation with correlation to lesion durability at a three month re-mapping procedure.
Collection of full blood before and 24 and 48 hours after the procedure to analyse activation of inflammation, coagulation, and also nevral tissue injury and endotelial injury due to ablation. Deviation of markers from the baseline value before the procedure will serve as a measure of activation. Markers analysed: troponin (ng/ml), D dimer (mg/l fibrinogen equivalent units), protein S100 (ng/ml), protein NSE (ng/ml), NT proBNP (pg/ml), high sensitivity CRP (mg/l), interleukin (IL) 6 (pg/ml), procalcitonin (ng/ml), fibrinogen (g/l), P selectin /pg/ml).
Postprocedurally pateints will undergo a remapping procedure three months later to determine pulmonary vein and left atrial posterior wall isolation durability.
Pateints will be followed up with clinical checkup and 1-7 day ECG holters at 3, 6, 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency ablation | Active comparator | Other: Radiofrequency ablationPulmonary vein and left atrial posterior wall isolation with point by point radiofrequency ablation. |
| Pulse field ablation | Experimental | Other: Pulse field ablationPulmonary vein and left atrial posterior wall isolation with point by point pulse field ablation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- atrial fibrillation recorded with 12-lead ECG, holter ECG or implantable device on two occasions at least one week apart
Key exclusion criteria (1 listed)
- history of previous catheter ablation, history of previous heart surgery, life expectancy less than one year, any lifethreatening severe acute condition, acute deep venous thrombosis, presence of intracardiac masses or thrombi.
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 |
|---|---|---|
| Pulse field ablationPoint by point isolation of pulmonary veins and left atrial posterior wall | Other | Pulse field ablation |
| Radiofrequency ablationPoint by point isolation of pulmonary veins and left atrial posterior wall | Other | Radiofrequency ablation |
Primary outcome
Durability of isolation
Time frame: 3 months
Testing for durability of pulmonary vein and left atrial posterior wall isolation in both study arms with high density endocardial remapping. Absence of electrical activity or voltage inside ablation lines of less than 0.05 mV or presence of exit block upon pacing with local capture will be considered as proof of pulmonary vein and posterior left atrial wall isolation.
3 secondary outcomes
Freedom from atrial arrhythmias
Time frame: 12 months
Intracardiac electrograms analysis
Time frame: 1 day
Recording of complications
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Jernej Štublar, BSE study chair
University Medical Centre Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulse field ablation and Radiofrequency ablation in people with Persistent Atrial Fibrillation and Longstanding Persistent Atrial Fibrillation, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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: under way, not looking for participants, as of the sponsor's last update on 11 Feb 2026. 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 Slovenia. 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?
This study is still under way. Results are not available in the source record yet.
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?
Durability of isolation (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2026.