Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort | Experimental | Long-standing and persistent atrial fibrillation undergoing catheter ablation mimicking cox-maze procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 month |
| Interventions | Initiations of antiarrhythmic drug therapy, number of cardioversions, number of repeat procedures after index procedure will be assessed. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tine Prolic Kalinsek, MD | UMCL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Centre Ljubljana | Ljubljana | Osrednjaslovenska | 1000 | Slovenia |
the data will be shared upon reasonable request.
01-MAR-2026 until 01-MAR-2030
Researchers upon reasonable request.
Not provided
Not provided
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
monocentric prospective nonrandomized cohort study
Not provided
Not provided
Not provided
Not provided
| 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. | 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. | 6 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |