NCT07446244

Catheter Ablation of Advanced Forms of Atrial Fibrillation

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University Medical Centre Ljubljana · Academic / Other
• Sex: All
• Age: 80 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Persistent Atrial Fibrillation
• Persistent Atrial Fibrillation Longstanding

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2026-03-25
• Primary completion: 2027-03-01
• Completion: 2028-03-01
• First posted: 2026-03-03
• Last updated: 2026-04-06

Locations

1 site across 1 country: Slovenia