Hybrid Ablation of Persistent and Long-standing Persistent Stand-alone Atrial Fibrillation

Study Overview
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Brief Summary
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This study evaluates in detail efficacy and safety (including neurological safety) of hybrid ablation of stand-alone, persistent and long-standing persistent atrial fibrillation (AF). An implantable ECG monitor will be implanted to all patients for rhythm monitoring. Neurological safety will be assessed by cerebral magnetic resonance, neuropsychological examination and periprocedural transcranial Doppler measurement.

Detailed Description
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Hybrid ablation (i.e. surgical thoracoscopic ablation, followed by catheter endocardial ablation) represent a new treatment option for patients with atrial fibrillation. 60 patients will undergo a two-stage, hybrid ablation, all of them will have an ECG monitoring device implanted and will be followed for up to three years. Neurological safety of both surgical and catheter procedures will be assessed by three examinations. Magnetic resonance will be performed before surgery, 5 days after surgery and at the 180 days visit to search for (subclinical) cerebral ischemia. Complex neuropsychological examination will be performed before surgery, afer 1 month after surgery and at 180 days visit to search for changes in cognitive functions, behavioral functions etc. Transcranial Doppler will be performed during surgical and catheter ablation to detect microembolic signals.

Official Title
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EndoMaze HYBRID project-a Detailed Assessment of Efficacy and Safety of Hybrid Ablation of Persistent and Long-standing Persistent Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: hybrid ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients age > 18 years Patients with persistent/long-standing persistent AF according to the standard EHRA definition. Patients with symptomatic AF that is refractory to at least one antiarrhythmic medication. Absence of significant structural heart disease (dilated cardiomyopathy, hypertrophic cardiomyopathy, valvular heart disease, untreated coronary artery disease) Ability to sign an informed consent Exclusion Criteria: Paroxysmal AF AF secondary to a reversible cause (i.e., thyreopathy, etc.) Indication for open-heart surgery (coronary artery bypass grafting, valve surgery, etc.) Severe left ventricle dysfunction that is clearly caused by some other cardiac disease (dilated cardiomyopathy, ischaemic heart disease, etc.) where the AF is clearly of secondary etiology Known severe pericardial and pleural adhesions (e.g., history of cardiac surgery)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| hybrid ablation<br>60 patients with stand-alone, persistent or long-standing persistent atrial fibrillation | Procedure: hybrid ablation<br>* Surgical thoracoscopic epicardial ablation (box-lesion) and left atrial appendage occlusion , followed (after 2-3months) by electrophysiological examination, and catheter ablation (completion of the box-lesion, cavotricuspid isthmus ablation and other ablation if indicated)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sinus rhythm (The Reveal LINQ Insertable Cardiac Monitoring System) | Number of patients with sinus rhythm, without detections of atrial arrhythmias (episodes longer than 30 seconds) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neurological safety (cerebral magnetic resonance (MR), neuropsychological changes - multiple questionnaires, Transcranial Doppler) | new ischaemic brain lesions on MR performed at the discharge from surgery and at the 180 days visit), neuropsychological changes measured by special questionnaires, that will be filled at 30 and 180 days visit, periprocedural Doppler - hits rates on periprocedural transcranial Doppler measurement during both surgery and catheter ablation | 180 days | 
| periprocedural complications - surgery | conversion to sternotomy, bleeding, thromboembolic events, tamponade, haemothorax, pneumothorax, pleural effusion, pneumonia | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation, Hybrid ablation