AFPFA ChampionNCT06646887
Comparison of Different Electroporation Systems in the Ablation Treatment of Atrial Fibrillation
A study testing Electroporation in people with AF and Ablation of Atrial Fibrillation, run by University Hospital Dubrava at 2 sites in Croatia.
Trial summary
The participant is invited to participate in a clinical study comparing three different techniques for treating atrial fibrillation (AF) called electroporation systems. Atrial fibrillation is an irregular heartbeat that can cause complications if left untreated. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- AF, Ablation of Atrial Fibrillation
- What is being tested?
- Electroporation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesCroatia
- Study dates
- 15 Oct 2024to 1 May 2025
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patients with prior ablation procedures. Contraindications for AF ablation (e.g., severe coagulopathy, left atrial appendage thrombus).
- Significant comorbidities impacting study outcomes.
Trial locations and contacts
2 sites in 1 country.
Croatia2 sites
Clinical Hospital Dubrava, Department of Cardiology
Zagreb, City of Zagreb, 10000
UHDubrava
Zagreb, 10 000
About this study
The participant is invited to participate in a clinical study comparing three different techniques for treating atrial fibrillation (AF) called electroporation systems. Atrial fibrillation is an irregular heartbeat that can cause complications if left untreated. The goal of this study is to determine which electroporation system is the most effective and safest for treating AF. These systems work by using electrical energy to disrupt abnormal heart tissue, helping to restore a normal heart rhythm.
Read the detailed description
The investigators are testing three different electroporation systems: Farapulse, PulseSelect, and Varipulse. Each of these systems uses a similar approach to treat AF, but they may work slightly differently. The investigators want to find out which one is best at permanently stopping the irregular heart rhythm, while also being the safest for patients.
What will happen during the study?
The patient will have two procedures:
First procedure: This is the initial ablation, where the doctors will use one of the three electroporation systems to treat the atrial fibrillation. During this procedure, the investigators will map the heart using a special tool to see exactly where the irregular rhythm is happening.
Second procedure: After about 3 months, the participant will return for a re-mapping procedure. This will allow the doctors to check if the treatment was successful and if any abnormal rhythms have come back. If necessary, the investigator will perform another ablation to correct any remaining problems.
Is it safe? All procedures are performed by experienced doctors who specialize in treating AF. Like any medical procedure, there are some risks, such as small chances of blood clots, injury to nearby tissues, or complications from the anesthesia. However, the electroporation systems are designed to minimize these risks, and the study will closely monitor your loved one for any complications.
What are the benefits of participating? The participant could benefit from receiving one of the latest treatments for atrial fibrillation. By participating, they will help doctors learn which system works best, which could help future patients with similar conditions. Additionally, the participant heart rhythm will be closely monitored, and if any problems arise, they will receive immediate care.
How long will it take? The study will last about 6 to 7 months, with the initial procedure taking place in the next few weeks and a follow-up re-mapping procedure approximately 12-14 weeks later.
- Conditions
- AF, Ablation of Atrial Fibrillation
- Being tested
- Electroporation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroporationOther
Unlike traditional thermal ablation techniques such as radiofrequency (RF) and cryoablation, the electroporation systems used in this study rely on pulsed electric fields (PEF) to selectively target and ablate cardiac tissue. This non-thermal mechanism reduces the risk of collateral damage to nearby structures, such as the esophagus, phrenic nerve, and coronary arteries.
| Study group | Role | What they receive |
|---|---|---|
| Varipluse, | Active comparator | Varipulse Arm - Participants in this arm will undergo ablation using the Varipulse system Receives: Other: Electroporation |
| PulseSelect | Active comparator | PulseSelect Arm - Participants in this arm will receive treatment with the PulseSelect system Receives: Other: Electroporation |
| Farpulse | Active comparator | Farapulse Arm - Participants in this arm will undergo ablation using the Farapulse electroporation system.
. Receives: Other: Electroporation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness and durability of the ablation procedure.
The percentage of patients who achieve complete and durable pulmonary vein isolation without reconnection, confirmed during the re-mapping procedure performed approximately 12-14 weeks after the initial ablation.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start15 Oct 2024
- Primary completion10 Apr 2025 (estimated)
- Study completion1 May 2025 (estimated)
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 AFStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Dubrava
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Jordan, University Hospital Dubrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06646887
- Sponsor's protocol ID
- Dubrava
- Other IDs
- 2024/0828-4
- Acronym
- PFA Champion
- Status last verified
- Jan 2025
- First submitted
- 2 Oct 2024
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient Privacy and Confidentiality: Sharing detailed individual data can raise concerns about the privacy of participants. Even with de-identification, there may be a risk of re-identifying participants, especially with a relatively small sample size and specific medical conditions like atrial fibrillation. Ethical Considerations: Ethical guidelines often require that participant data is protected and only used for the specific purposes outlined in the consent forms. Sharing IPD might exceed the scope of what participants agreed to when they enrolled in the study. Regulatory Restrictions: Some regulatory bodies or institutions may impose strict guidelines on the sharing of sensitive medical data to prevent misuse or ensure data security, particularly when dealing with experimental procedures or novel technologies like electroporation systems.
Publications
Reddy VY, Dukkipati SR, Neuzil P, Anic A, Petru J, Funasako M, Cochet H, Minami K, Breskovic T, Sikiric I, Sediva L, Chovanec M, Koruth J, Jais P. Pulsed Field Ablation of Paroxysmal Atrial Fibrillation: 1-Year Outcomes of IMPULSE, PEFCAT, and PEFCAT II. JACC Clin Electrophysiol. 2021 May;7(5):614-627. doi: 10.1016/j.jacep.2021.02.014. Epub 2021 Apr 28.
PubMed 33933412
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Electroporation Systems in the Ablation Treatment of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT06646887
- Acronym / sponsor ID
- PFA Champion / Dubrava
- Conditions
- AF, Ablation of Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital DubravaUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 10 Apr 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 17 Oct 2024 (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.
The participant is invited to participate in a clinical study comparing three different techniques for treating atrial fibrillation (AF) called electroporation systems. Atrial fibrillation is an irregular heartbeat that can cause complications if left untreated. The goal of this study is to determine which electroporation system is the most effective and safest for treating AF. These systems work by using electrical energy to disrupt abnormal heart tissue, helping to restore a normal heart rhythm.
Detailed description
The investigators are testing three different electroporation systems: Farapulse, PulseSelect, and Varipulse. Each of these systems uses a similar approach to treat AF, but they may work slightly differently. The investigators want to find out which one is best at permanently stopping the irregular heart rhythm, while also being the safest for patients.
What will happen during the study?
The patient will have two procedures:
First procedure: This is the initial ablation, where the doctors will use one of the three electroporation systems to treat the atrial fibrillation. During this procedure, the investigators will map the heart using a special tool to see exactly where the irregular rhythm is happening.
Second procedure: After about 3 months, the participant will return for a re-mapping procedure. This will allow the doctors to check if the treatment was successful and if any abnormal rhythms have come back. If necessary, the investigator will perform another ablation to correct any remaining problems.
Is it safe? All procedures are performed by experienced doctors who specialize in treating AF. Like any medical procedure, there are some risks, such as small chances of blood clots, injury to nearby tissues, or complications from the anesthesia. However, the electroporation systems are designed to minimize these risks, and the study will closely monitor your loved one for any complications.
What are the benefits of participating? The participant could benefit from receiving one of the latest treatments for atrial fibrillation. By participating, they will help doctors learn which system works best, which could help future patients with similar conditions. Additionally, the participant heart rhythm will be closely monitored, and if any problems arise, they will receive immediate care.
How long will it take? The study will last about 6 to 7 months, with the initial procedure taking place in the next few weeks and a follow-up re-mapping procedure approximately 12-14 weeks later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Varipluse, | Active comparator | Other: ElectroporationVaripulse Arm - Participants in this arm will undergo ablation using the Varipulse system |
| PulseSelect | Active comparator | Other: ElectroporationPulseSelect Arm - Participants in this arm will receive treatment with the PulseSelect system |
| Farpulse | Active comparator | Other: ElectroporationFarapulse Arm - Participants in this arm will undergo ablation using the Farapulse electroporation system. . |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Patients with prior ablation procedures. Contraindications for AF ablation (e.g., severe coagulopathy, left atrial appendage thrombus).
- Significant comorbidities impacting study outcomes.
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 |
|---|---|---|
| ElectroporationUnlike traditional thermal ablation techniques such as radiofrequency (RF) and cryoablation, the electroporation systems used in this study rely on pulsed electric fields (PEF) to selectively target and ablate cardiac tissue. This non-thermal mechanism reduces the risk of collateral damage to nearby structures, such as the esophagus, phrenic nerve, and coronary arteries. | Other | Farpulse, PulseSelect, Varipluse, |
Primary outcome
Effectiveness and durability of the ablation procedure.
Time frame: Three months
The percentage of patients who achieve complete and durable pulmonary vein isolation without reconnection, confirmed during the re-mapping procedure performed approximately 12-14 weeks after the initial ablation.
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 1 Apr 2025.
- Background: PubMed 33933412Reddy VY, Dukkipati SR, Neuzil P, Anic A, Petru J, Funasako M, Cochet H, Minami K, Breskovic T, Sikiric I, Sediva L, Chovanec M, Koruth J, Jais P. Pulsed Field Ablation of Paroxysmal Atrial Fibrillation: 1-Year Outcomes of IMPULSE, PEFCAT, and PEFCAT II. JACC Clin Electrophysiol. 2021 May;7(5):614-627. doi: 10.1016/j.jacep.2021.02.014. Epub 2021 Apr 28.
- Individual participant dataSharing planned: No. Patient Privacy and Confidentiality: Sharing detailed individual data can raise concerns about the privacy of participants. Even with de-identification, there may be a risk of re-identifying participants, especially with a relatively small sample size and specific medical conditions like atrial fibrillation. Ethical Considerations: Ethical guidelines often require that participant data is protected and only used for the specific purposes outlined in the consent forms. Sharing IPD might exceed the scope of what participants agreed to when they enrolled in the study. Regulatory Restrictions: Some regulatory bodies or institutions may impose strict guidelines on the sharing of sensitive medical data to prevent misuse or ensure data security, particularly when dealing with experimental procedures or novel technologies like electroporation systems.
Related trials for AF
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Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
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Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
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Hummingbird ICE Study
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Active, not recruitingObservational study
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroporation in people with AF and Ablation of Atrial Fibrillation, run by University Hospital Dubrava at 2 sites in Croatia.
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 0 inclusion and 2 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 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Croatia. 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?
Effectiveness and durability of the ablation procedure. (time frame: Three 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 NCT06646887, 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 1 Apr 2025; AzTrials last refreshed its copy on 7 Nov 2026.