Persistent Atrial Fibrillation, Persistent Atrial Fibrillation Longstanding
Conditions
Keywords
pulsed field ablation, atrial fibrillation, cox maze
Brief 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.
Interventions
DEVICEEndovascular 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.
Sponsors
University Medical Centre Ljubljana
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
monocentric prospective nonrandomized cohort study
Eligibility
Sex/Gender
ALL
Age
No minimum to 80 Years
Healthy volunteers
No
Inclusion criteria
* persistent atrial fibrillation or long-standing persistent atrial fibrillation * severely enlarged left atrium (LAVI above 50 ml/m2)
Exclusion criteria
* 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 * severe valvular disease requiring intervention * previous ablation in left atrium * secondary atrial fibrillation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Atrial arrhythmia recurrence | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of endovascular Cox maze procedure | 12 month | Atrial fibrillation burden will be assessed with 7-day Holter ECG at 3, 6 and 12 months post procedure. |
| Interventions | 12 months | Initiations of antiarrhythmic drug therapy, number of cardioversions, number of repeat procedures after index procedure will be assessed. |
| Durability of ablation lines and isolations | 3 months | Number of durable blocks across ablation lines and durable isolations (pulmonary veins, superior vena cava) on invasive remap at 3 months will be assessed. |
| Safety of catheter ablation procedure | 6 months | 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. |
Countries
Slovenia
Contacts
PRINCIPAL_INVESTIGATORTine Prolic Kalinsek, MD
UMCL
Outcome results
None listed