Charles University, Third Faculty of Medicine
Prague, 10000, Czechia
NCT Number: NCT02832206
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.
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Notify Me18 year–80 year
All sexes
Observational
Prague, 10000, Czechia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
Time frame: 1 year
Number of patients with sinus rhythm, without detections of atrial arrhythmias (episodes longer than 30 seconds)
Time frame: 180 days
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
Time frame: 30 days
conversion to sternotomy, bleeding, thromboembolic events, tamponade, haemothorax, pneumothorax, pleural effusion, pneumonia
Time frame: 1 year
changes in quality of life, measured by questionnaires AFEQT
Charles University, Czech Republic
Other
EndoMaze HYBRID project-a Detailed Assessment of Efficacy and Safety of Hybrid Ablation of Persistent and Long-standing Persistent Atrial Fibrillation
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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