Catheter Ablation of Advanced Forms of Atrial Fibrillation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Endovascular ablation set mimicking cox maze 4 procedure..
- Who it may be relevant to
- Registry conditions: Persistent Atrial Fibrillation, Persistent Atrial Fibrillation Longstanding. Basic parameters: up to 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Slovenia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- 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.
Primary outcome measures
- Atrial arrhythmia recurrence [Time frame: 12 months]
Secondary outcome measures (4)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Slovenia · 1 center
- University Medical Centre Ljubljana — Ljubljana
Identifiers
NCT: NCT07446244 · 145780304