Persistent Atrial FibrillationENDO MAZENCT07446244
Catheter Ablation of Advanced Forms of Atrial Fibrillation
A study testing Endovascular ablation set mimicking cox maze 4 procedure. in people with Persistent Atrial Fibrillation and Persistent Atrial Fibrillation Longstanding, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
The purpose of this study is to evaluate feasibility, safety, and efficacy of pulmonary vein isolation combined with posterior left atrial isolation and multiple linear lesions in both atria in patients with persistent and long-standing persistent atrial fibrillation. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Persistent Atrial Fibrillation, Persistent Atrial Fibrillation Longstanding
- What is being tested?
- Endovascular ablation set mimicking cox maze 4 procedure.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSlovenia
- Study dates
- 25 Mar 2026to 1 Mar 2028
- 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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- persistent atrial fibrillation or long-standing persistent atrial fibrillation
- severely enlarged left atrium (LAVI above 50 ml/m2)
Who cannot join
- contraindications for electroporation
- contraindications for general anaesthesia
- age above 80 years
- less than 1 year life expectancy
- thrombus formation in left atrium
- acute life-threatening disease
Show all 9Show fewer
- severe valvular disease requiring intervention
- previous ablation in left atrium
- secondary atrial fibrillation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia1 site
University Medical Centre Ljubljana
Ljubljana, Osrednjaslovenska, 1000
About this study
The purpose of this study is to evaluate feasibility, safety, and efficacy of pulmonary vein isolation combined with posterior left atrial isolation and multiple linear lesions in both atria in patients with persistent and long-standing persistent atrial fibrillation.
Read the detailed description
Patients with long-standing and persistent atrial fibrillation with severely dilated left atrium will undergo pulmonary vein isolation, box-lesion set of posterior wall, lateral mitral line (Marshall vein ablation and coronary sinus ablation per operator's discretion, anterior line, cavotricuspid line, superior caval vein isolation, intercaval line and inferior septal line. Ablations will be performed with either radiofrequency energy or pulsed field ablation at operator's discretion. Block at each line will be checked at the end of the procedure. The procedure will be performed with compliance of producer recommendation and hospital protocol.
All patients will be invited back at three months after index procedure for an invasive remap. At the remap procedure, pulmonary veins and posterior wall will be checked for isolation and all the additional lines will be checked for conduction block. Any gaps in lines will be ablated per operator's discretion.
Patients will undergo a period follow-up visit at 3, 6, and 12-month period. They will undergo a medical history taking, physical examination, ECG, and 7-day Holter ECG. Any documented atrial arrhythmia lasting more than 30 seconds after 8 week blanking period will be documented as a recurrence of atrial fibrillation.
- Being tested
- Endovascular ablation set mimicking cox maze 4 procedure.
- Keywords
- pulsed field ablation, atrial fibrillation, cox maze
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular ablation set mimicking cox maze 4 procedure.Device
Endovascular pulmonary vein isolation, posterior left atrial isolation and multiple linear lesions in both atria using electroporation and radiofrequency energy.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Experimental | Long-standing and persistent atrial fibrillation undergoing catheter ablation mimicking cox-maze procedure Receives: Device: Endovascular ablation set mimicking cox maze 4 procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial arrhythmia recurrence
Atrial fibrillation/atrial tachycardia/atrial undulation lasting more than 30s after 8 week blanking period and without antiarrhythmic drug therapy. Assessed with 7-day Holter ECG at 3, 6, 12 months after index procedure.
Measured: 12 months
Secondary outcomes (4)
Efficacy of endovascular Cox maze procedure
Atrial fibrillation burden will be assessed with 7-day Holter ECG at 3, 6 and 12 months post procedure.
Measured: 12 month
Interventions
Initiations of antiarrhythmic drug therapy, number of cardioversions, number of repeat procedures after index procedure will be assessed.
Measured: 12 months
Durability of ablation lines and isolations
Number of durable blocks across ablation lines and durable isolations (pulmonary veins, superior vena cava) on invasive remap at 3 months will be assessed.
Measured: 3 months
Safety of catheter ablation procedure
Incidence of adverse events defined as events, which require prolonged hospitalization, additional intervention or permanent damage to patients health or cause death in a 180 day period after catheter ablation.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start25 Mar 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2028 (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
- Not applicable
- Intervention model
- Single group
- Model description
- monocentric prospective nonrandomized cohort study
- 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
- Tine Prolic Kalinsek, MD, Principal investigator, UMCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07446244
- Sponsor's protocol ID
- 145780304
- Acronym
- ENDO MAZE
- Status last verified
- Mar 2026
- First submitted
- 19 Feb 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the data will be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Catheter Ablation of Advanced Forms of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT07446244
- Acronym / sponsor ID
- ENDO MAZE / 145780304
- Keywords
- pulsed field ablation, atrial fibrillation, cox maze
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 25 Mar 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 3 Mar 2026 (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 purpose of this study is to evaluate feasibility, safety, and efficacy of pulmonary vein isolation combined with posterior left atrial isolation and multiple linear lesions in both atria in patients with persistent and long-standing persistent atrial fibrillation.
Detailed description
Patients with long-standing and persistent atrial fibrillation with severely dilated left atrium will undergo pulmonary vein isolation, box-lesion set of posterior wall, lateral mitral line (Marshall vein ablation and coronary sinus ablation per operator's discretion, anterior line, cavotricuspid line, superior caval vein isolation, intercaval line and inferior septal line. Ablations will be performed with either radiofrequency energy or pulsed field ablation at operator's discretion. Block at each line will be checked at the end of the procedure. The procedure will be performed with compliance of producer recommendation and hospital protocol.
All patients will be invited back at three months after index procedure for an invasive remap. At the remap procedure, pulmonary veins and posterior wall will be checked for isolation and all the additional lines will be checked for conduction block. Any gaps in lines will be ablated per operator's discretion.
Patients will undergo a period follow-up visit at 3, 6, and 12-month period. They will undergo a medical history taking, physical examination, ECG, and 7-day Holter ECG. Any documented atrial arrhythmia lasting more than 30 seconds after 8 week blanking period will be documented as a recurrence of atrial fibrillation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- monocentric prospective nonrandomized cohort study
| Arm | Type | Receives |
|---|---|---|
| Cohort | Experimental | Device: Endovascular ablation set mimicking cox maze 4 procedure.Long-standing and persistent atrial fibrillation undergoing catheter ablation mimicking cox-maze procedure |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- persistent atrial fibrillation or long-standing persistent atrial fibrillation
- severely enlarged left atrium (LAVI above 50 ml/m2)
Key exclusion criteria (9 listed)
- contraindications for electroporation
- contraindications for general anaesthesia
- age above 80 years
- less than 1 year life expectancy
- thrombus formation in left atrium
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 |
|---|---|---|
| Endovascular ablation set mimicking cox maze 4 procedure.Endovascular pulmonary vein isolation, posterior left atrial isolation and multiple linear lesions in both atria using electroporation and radiofrequency energy. | Device | Cohort |
Primary outcome
Atrial arrhythmia recurrence
Time frame: 12 months
Atrial fibrillation/atrial tachycardia/atrial undulation lasting more than 30s after 8 week blanking period and without antiarrhythmic drug therapy. Assessed with 7-day Holter ECG at 3, 6, 12 months after index procedure.
4 secondary outcomes
Efficacy of endovascular Cox maze procedure
Time frame: 12 month
Interventions
Time frame: 12 months
Durability of ablation lines and isolations
Time frame: 3 months
Safety of catheter ablation procedure
Time frame: 6 months
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 6 Apr 2026.
- Individual participant dataSharing planned: Yes. the data will be shared upon reasonable request.
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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.
Tine Prolic Kalinsek, MD principal investigator
UMCL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular ablation set mimicking cox maze 4 procedure. in people with Persistent Atrial Fibrillation and Persistent Atrial Fibrillation Longstanding, 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 2 inclusion and 9 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: enrolling by invitation, as of the sponsor's last update on 6 Apr 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?
Atrial arrhythmia recurrence (time frame: 12 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 6 Apr 2026.