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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hybrid ablation | 60 patients with stand-alone, persistent or long-standing persistent atrial fibrillation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hybrid ablation | Procedure | 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) |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| QoL measurement | changes in quality of life, measured by questionnaires AFEQT | 1 year |
Inclusion Criteria:
Exclusion Criteria:
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patients with symptomatic, drug-resistant, stand-alone, persistent or long-standing persistent atrial fibrillation
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| Name | Affiliation | Role |
|---|---|---|
| Zbynek Straka, MD, PhD | Vascular surgery, University hospital Královské Vinohrady, Prague | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charles University, Third Faculty of Medicine | Prague | 10000 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29360987 | Derived | Osmancik P, Budera P, Zdarska J, Herman D, Petr R, Fojt R, Straka Z. Residual echocardiographic and computed tomography findings after thoracoscopic occlusion of the left atrial appendage using the AtriClip PRO device. Interact Cardiovasc Thorac Surg. 2018 Jun 1;26(6):919-925. doi: 10.1093/icvts/ivx427. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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|
| 180 days |
| periprocedural complications - surgery | conversion to sternotomy, bleeding, thromboembolic events, tamponade, haemothorax, pneumothorax, pleural effusion, pneumonia | 30 days |
| D013568 |
| Pathological Conditions, Signs and Symptoms |