An interventional study of In the ICE group, positioning/contact of the ablation catheter will be performed under ICE guidance. In the mapping group, guidance will be performed using three-dimensional electroanatomical mapping. in Paroxysmal Atrial Fibrillation (PAF), sponsored by Mitera Hospital. Recruiting at 8 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Mitera Hospital · Not applicable, Interventional, and Treatment
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Among 47 studies in Atrial Fibrillation with a site in Croatia — 17 open to participants now, 24 under way, 2 of them phase 3. Atrial Fibrillation · Croatia.
Among the 47 studies in Atrial Fibrillation with a site in Croatia, this one is the 12th largest by planned enrollment of the 38 interventional ones that give a count, is one of 7 that started in 2026, is one of 30 with no phase, reaches primary completion later than 21 of the 23 other live ones, and was the 46th registered.
4,009 studies on the registry are indexed under Atrial Fibrillation; 960 are open to participants now.
Browse Atrial Fibrillation studies →17 of the 47 studies in Atrial Fibrillation with a site in Croatia are open now. Recruiting first, the newest first:
Boston Scientific Corporation · Sites in Croatia, Belgium, France and 2 more countries
Ages 18+
LUMA Vision Ltd. · Sites in Croatia
Ages 18+
Boston Scientific Corporation · Sites in Croatia, Czechia, Hong Kong and 1 more country
Ages 18+
University Hospital Dubrava · Sites in Croatia
Ages 18+
LUMA Vision Ltd. · Sites in Croatia, Czechia, Lithuania
Ages 18+
A study can be open while its sites in Croatia have not opened yet or have stopped. Only those recruiting at a site in Croatia →
Of the 611 Atrial Fibrillation studies recruiting now, 407 (67%) set no upper age limit and 43 (7%) stop at 75 or younger; 21 take children under 18; 43 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
47 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 7 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 292 is above the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Median enrollment 200 across the 38 interventional studies, 400 across the 9 observational. Of the 22 that completed or were terminated, 14 (64%) have results posted.
This tab as a report to print or save as PDF → With an account.
34 of 47 have an industry lead sponsor. The 10 most frequent:
Mitera Hospital is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
Mitera Hospital has 2 studies filed under Atrial Fibrillation — fewer than ten, so there is no comparison to draw.
9 of the studies in Atrial Fibrillation with a site in Croatia that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05757869Phase 3Janssen Research & Development, LLCA Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation | 2026-12-08 |
| NCT07271238LUMA Vision Ltd.Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures | 2026-12-15 |
| NCT07210151LUMA Vision Ltd.Anatomical Navigation for Guided Electrophysiology in AFL and AFib | 2026-12-16 |
| NCT07610018Ivan ZeljkovicCerebral Microembolization During Pulmonary Vein Isolation: Comparison of Different Pulsed Field Ablation Systems | 2027-01-01 |
| NCT06823466University of L'AquilaAdvancing Knowledge in Ischemic Stroke Patients on Oral Anticoagulants | 2027-02-12 |
Add all 9 to your calendar (.ics) → With an account.
Among the 47 studies in Atrial Fibrillation with a site in Croatia, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a prospective, randomized clinical trial, which will be conducted in selected European centers. The objective is to compare two commonly used strategies to guide pulsed-field ablation (PFA) in patients with paroxysmal atrial fibrillation (AF). Patients with paroxysmal AF planned to undergo PFA will be randomized to intracardiac echocardiography (ICE)-guided or electroanatomical mapping-guided (OPAL HDx mapping system) ablation procedure. The primary efficacy endpoint will be freedom from atrial arrhythmia (AF, atrial flutter, atrial tachycardia) recurrence off antiarrhythmic drug therapy and without the need for electrical cardioversion or repeat ablation, with a follow-up duration of 12 months. The primary safety endpoint will be the incidence of predefined safety outcomes.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intracardiac echocardiography-guided group
Other: In the ICE group, positioning/contact of the ablation catheter will be performed under ICE guidance. In the mapping group, guidance will be performed using three-dimensional electroanatomical mapping.
Three-dimensional electroanatomical mapping-guided group
Other: In the ICE group, positioning/contact of the ablation catheter will be performed under ICE guidance. In the mapping group, guidance will be performed using three-dimensional electroanatomical mapping.
Ablation procedure (electrical isolation of the pulmonary veins) will be performed according to routine clinical practice. In the ICE group, positioning of the ablation catheter and confirmation of contact with the targeted tissue will be performed under ICE guidance. In the mapping group, guidance will be performed using three-dimensional electroanatomical mapping with the FARAVIEW system (OPAL HDx, software version 7.0, Boston Scientific). PFA will be delivered using field-tag feature ensuring number of applications and stacking as suggested by IFU. In the mapping group, the use of ICE will only be allowed to guide the transseptal puncture in order to ensure procedural safety in both groups.
Arrhythmia-free survival
Primary efficacy endpoint: Number of patients without atrial arrhythmia recurrence (AF, atrial flutter, atrial tachycardia) off antiarrhythmic drug therapy and without the need for electrical cardioversion or repeat ablation, after a blanking period of 2 months. A recurrence is defined as any episode of atrial tachyarrhythmia recorded on standard 12-lead ECG or any episode lasting ≥6 minutes on Holter monitor (or CIED with atrial sensing capabilities).
Time frame: up to 12 months
Complications
Composite primary safety endpoint: Number of participants experiencing at least one of the following prespecified complications (major safety events): Stroke, transient ischemic attack, or systemic embolism Coronary spasm Myocardial infarction Cardiac tamponade Clinically relevant esophageal complication Clinically relevant pulmonary vein stenosis Diaphragmatic paralysis persisting for more than 6 months Acute kidney injury Bleeding requiring transfusion Major vascular complication Pericarditis or vagal nerve injury Heart failure or pulmonary edema Sudden death within 30 days of the procedure Any device- or procedure-related death For the composite primary safety endpoint, each participant will be counted only once, regardless of the number or type of qualifying events experienced.
Time frame: up to 12 months
Arrhythmia-free survial (>30 sec)
Number of patients without atrial arrhythmia recurrence (AF, atrial flutter, atrial tachycardia) lasting \>30 seconds on Holter monitoring, off antiarrhythmic drug therapy and without the need for electrical cardioversion or repeat ablation, after an initial blanking period of 2 months.
Time frame: up to 12 months
Procedure time (min)
Time from femoral puncture to catheter removal (minutes).
Time frame: Periprocedural
Left atrial dwell time (min)
Time from transseptal puncture to catheter withdrawal from the left atrium (minutes).
Time frame: Periprocedural
Number of lesions
Total number of ablation lesions deployed.
Time frame: Periprocedural
Fluoroscopy time (min)
Duration of fluoroscopy (minutes).
Time frame: Periprocedural
Fluoroscopy dose (cGy·cm²)
Total fluoroscopy dose (measured in cGy·cm²).
Time frame: Periprocedural
Started Aug 2026 (actual). Primary completion is estimated for Dec 2028, 28 months after the start.
Of 795 non-industry interventional studies with no phase under Atrial Fibrillation, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 59. This study's planned 28 months is below that.
Counting every sponsor, half of 1,050 studies reached it within 33 months; a quarter within 18 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
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