Atrial FibrillationBURST-AFNCT05572047
Coherent Sine Burst (CSE) Electroporation System Pilot Study in Patients With Atrial Fibrillation
A study testing Arga Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System in people with Atrial Fibrillation, run by Arga Medtech SA at 3 sites in 2 countries.
Trial summary
To evaluate the safety and efficiency of the Arga Medtech CSE Ablation System in the treatment of atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Arga Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 11 Oct 2022to 24 Apr 2026
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for ablation of paroxysmal or persistent AF
- Willingness, ability, and commitment to participate in baseline and follow-up evaluations for the duration of the study
- Willing and able to give informed consent
- Failed at least one antiarrhythmic drug (AAD) (Class I to IV) as evidenced by recurrent symptomatic AF or intolerable or contraindicated to the AAD
Who cannot join
- Contraindication to AF ablation, TEE or anticoagulation
- Duration of continuous AF lasting longer than 12 months
- History of previous LA ablation or surgical treatment of AF/AT/AFL
- AF secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause
- Structural heart disease described as:
- LVEF <30% based on TTE within 6 months of procedure
Show all 21Show fewer
- Left atrial size > 50mm based on TTE within 6 months of procedure (parasternal view)
- An implanted pacemaker or ICD
- Previous cardiac surgery, ventriculotomy, or atriotomy (excluding atriotomy for CABG)
- Previous cardiac valvular surgical or percutaneous procedure or prosthetic valve
- Interatrial baffle, closure device, patch, ASD or PFO
- Presence of a left atrial appendage occlusion device
- CABG or PTCA procedure within the last 6 months
- Unstable angina or ongoing myocardial ischemia
- Myocardial infarction within the previous 6 months
- Hypertrophic cardiomyopathy defined as left ventricular septal wall thickness > 1.5cm
- History of blood clotting or bleeding disease
- Prior history within the previous 6 months of documented cerebral infarction, TIA or system embolism
- Pregnant or lactating (current or anticipated within study follow-up)
- Current enrollment in any other study protocol where testing or results from that study may interfere with the procedure or outcomes measurement for this study
- Any other condition, in the judgment of the investigator, makes the patient a poor candidate for this procedure, the study or compliance with the protocol
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Croatia2 sites
University Hospital of Split
Split, 21 000
KBC Zagreb
Zagreb, HR-10 000
Georgia1 site
Israeli-Georgian Medical Research Clinic Helthycore Ltd
Tbilisi, 0112
About this study
To evaluate the safety and efficiency of the Arga Medtech CSE Ablation System in the treatment of atrial fibrillation.
Read the detailed description
A prospective, single-arm, multi-center, multi-national, non-randomized study designed to provide clinical data to support the use of the Arga Medtech System in the ablation of atrial fibrillation.
Patients with paroxysmal AF will be treated using the Arga Medtech System to achieve pulmonary vein isolation (PVI) (and cavo-tricuspid isthmus (CTI) ablation as appropriate if history of CTI flutter or inducible flutter during procedure)
Patients with persistent AF will be treated using the Arga Medtech System to achieve PVI and posterior wall (PW) ablation (CTI ablation as above).
Patients will be remapped at 90 days post the index procedure to confirm absence of PV reconnection and durability of any additional lesion sets performed. Re-ablation is permitted during the remapping procedure if indicated. Re-ablation resets the 90-day blanking period.
Additional follow-ups will be conducted at 7 days, 30 days, 180 days and 360 days post the index or re-ablation procedure.
- Conditions
- Atrial Fibrillation
- Being tested
- Arga Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System
- Keywords
- Atrial Fibrillation, Ablation, Coherent Sine-Burst, Electroporation, CSE
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arga Medtech Coherent Sine-Burst Electroporation (CSE) Ablation SystemDevice
Also called CSE
Use of coherent sine-burst electroporation to ablate paroxysmal and persistent AF
| Study group | Role | What they receive |
|---|---|---|
| Coherent Sine-Burst Electroporation for AF | Experimental | Patients with paroxysmal AF will receive treatment using the Arga Medtech Coherent Sine-Burst Electroporation ablation system to achieve pulmonary vein isolation (plus cavo-tricuspid isthmus ablation as necessary)
Patients with persistent AF will receive treatment using the Arga Medtech Coherent Sine-Burst Electroporation ablation system to achieve pulmonary vein isolation and posterior wall ablation (and cavo-tricuspid isthmus ablation as necessary) Receives: Device: Arga Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious system and procedure-related events
Incidence of system-related and procedure-related serious adverse events (SAEs).
Measured: Within one week (7 days) post-procedure)
Procedural Success
Number of patients that achieve procedural success defined as isolation of the pulmonary veins at the index or re-mapping procedure.
Measured: Acute and/or up to 90 days post procedure
Chronic isolation of the pulmonary veins
Rate of patients and targeted pulmonary veins with documented electrical isolation of the pulmonary veins, assessed by entrance and exit block during a mapping procedure ~90-days post procedure.
Measured: 90 to 180 days post index procedure
Secondary outcomes (3)
Freedom from documented atrial fibrillation (AF)
Proportion of patients free from documented AF > or = 30 seconds of AF during follow-up.
Measured: Up to 455 days post-index procedure
Freedom from documented atrial arrhythmias (AF, AT and AFL)
Freedom from documented atrial arrhythmias (AF, AT and AFL) > or = to 30 seconds during follow-up.
Measured: Up to 455 days post-index procedure
Freedom from documented symptomatic recurrence of atrial arrhythmias
Freedom from recurrence of documented atrial arrhythmias (AF, AT and AFL) > or = to 30 seconds during follow-up.
Measured: Up to 455 days post-index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start11 Oct 2022
- Primary completion24 Apr 2026
- Study completion24 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Non-randomized, multi-center
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arga Medtech SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ante Anic, MD, Principal investigator, University Hospital of SplitGiorgi Papiashvili, Principal investigator, Israeli-Georgian Medical Research Clinic Helsicore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572047
- Sponsor's protocol ID
- CIP CSR 01-2022
- Acronym
- BURST-AF
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2022
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Anic A, Velagic V, Papiashvili G, Sikiric I, Lorenzo M, Prepolec I, Aranza I, Kapanadze N, Dagelic M, Breskovic T, Jurisic Z. Sine wave electroporation in patients with atrial fibrillation: Initial results of the BURST-AF study. Heart Rhythm. 2025 Aug;22(8):1946-1956. doi: 10.1016/j.hrthm.2025.04.042. Epub 2025 Apr 26.
PubMed 40294734
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coherent Sine Burst (CSE) Electroporation System Pilot Study in Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT05572047
- Acronym / sponsor ID
- BURST-AF / CIP CSR 01-2022
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Ablation, Coherent Sine-Burst, Electroporation, CSE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Arga Medtech SAIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- 24 Apr 2026 (actual)
- Study completion
- 24 Apr 2026 (actual)
- First posted
- 7 Oct 2022 (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.
To evaluate the safety and efficiency of the Arga Medtech CSE Ablation System in the treatment of atrial fibrillation.
Detailed description
A prospective, single-arm, multi-center, multi-national, non-randomized study designed to provide clinical data to support the use of the Arga Medtech System in the ablation of atrial fibrillation.
Patients with paroxysmal AF will be treated using the Arga Medtech System to achieve pulmonary vein isolation (PVI) (and cavo-tricuspid isthmus (CTI) ablation as appropriate if history of CTI flutter or inducible flutter during procedure)
Patients with persistent AF will be treated using the Arga Medtech System to achieve PVI and posterior wall (PW) ablation (CTI ablation as above).
Patients will be remapped at 90 days post the index procedure to confirm absence of PV reconnection and durability of any additional lesion sets performed. Re-ablation is permitted during the remapping procedure if indicated. Re-ablation resets the 90-day blanking period.
Additional follow-ups will be conducted at 7 days, 30 days, 180 days and 360 days post the index or re-ablation procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non-randomized, multi-center
| Arm | Type | Receives |
|---|---|---|
| Coherent Sine-Burst Electroporation for AF | Experimental | Device: Arga Medtech Coherent Sine-Burst Electroporation (CSE) Ablation SystemPatients with paroxysmal AF will receive treatment using the Arga Medtech Coherent Sine-Burst Electroporation ablation system to achieve pulmonary vein isolation (plus cavo-tricuspid isthmus ablation as necessary) Patients with persistent AF will receive treatment using the Arga Medtech Coherent Sine-Burst Electroporation ablation system to achieve pulmonary vein isolation and posterior wall ablation (and cavo-tricuspid isthmus ablation as necessary) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Scheduled for ablation of paroxysmal or persistent AF
- Willingness, ability, and commitment to participate in baseline and follow-up evaluations for the duration of the study
- Willing and able to give informed consent
- Failed at least one antiarrhythmic drug (AAD) (Class I to IV) as evidenced by recurrent symptomatic AF or intolerable or contraindicated to the AAD
Key exclusion criteria (21 listed)
- Contraindication to AF ablation, TEE or anticoagulation
- Duration of continuous AF lasting longer than 12 months
- History of previous LA ablation or surgical treatment of AF/AT/AFL
- AF secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause
- Structural heart disease described as:
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 |
|---|---|---|
| Arga Medtech Coherent Sine-Burst Electroporation (CSE) Ablation SystemAlso: CSEUse of coherent sine-burst electroporation to ablate paroxysmal and persistent AF | Device | Coherent Sine-Burst Electroporation for AF |
Primary outcome
Serious system and procedure-related events
Time frame: Within one week (7 days) post-procedure)
Incidence of system-related and procedure-related serious adverse events (SAEs).
Procedural Success
Time frame: Acute and/or up to 90 days post procedure
Number of patients that achieve procedural success defined as isolation of the pulmonary veins at the index or re-mapping procedure.
Chronic isolation of the pulmonary veins
Time frame: 90 to 180 days post index procedure
Rate of patients and targeted pulmonary veins with documented electrical isolation of the pulmonary veins, assessed by entrance and exit block during a mapping procedure ~90-days post procedure.
3 secondary outcomes
Freedom from documented atrial fibrillation (AF)
Time frame: Up to 455 days post-index procedure
Freedom from documented atrial arrhythmias (AF, AT and AFL)
Time frame: Up to 455 days post-index procedure
Freedom from documented symptomatic recurrence of atrial arrhythmias
Time frame: Up to 455 days post-index procedure
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 28 Oct 2026.
- Derived from this study: PubMed 40294734Anic A, Velagic V, Papiashvili G, Sikiric I, Lorenzo M, Prepolec I, Aranza I, Kapanadze N, Dagelic M, Breskovic T, Jurisic Z. Sine wave electroporation in patients with atrial fibrillation: Initial results of the BURST-AF study. Heart Rhythm. 2025 Aug;22(8):1946-1956. doi: 10.1016/j.hrthm.2025.04.042. Epub 2025 Apr 26.
- 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.
Ante Anic, MD principal investigator
University Hospital of Split
Giorgi Papiashvili principal investigator
Israeli-Georgian Medical Research Clinic Helsicore
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arga Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System in people with Atrial Fibrillation, run by Arga Medtech SA at 3 sites in 2 countries.
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 4 inclusion and 21 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 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Croatia, Georgia. 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?
Serious system and procedure-related events (time frame: Within one week (7 days) post-procedure)). The study lists 3 primary outcomes in all. 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 NCT05572047, which also lists 1 linked publication.
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 28 Oct 2026.