Single-stage Pulmonary Vein Isolation Combined With Percutaneous Left Atrial Appendage Occluder Implantation in Patients With Recent Onset Ischemic Stroke and Atrial Fibrillation

Ki vehet részt

• Ischemic stroke within 2-12 weeks after randomization with or without reperfusion therapy, confirmed by imaging studies (CT or MRI) that led to mild to moderate psychomotor dysfunction (mRS 0-3; NIHSS <16 points) and was treated with early neurological rehabilitation or was exempt from neurological rehabilitation on account of excellent psychomotor function. An obligatory criterion is persistence of symptoms for >24 h
• Diagnosis of paroxysmal or persistent atrial fibrillation on the basis of 12-lead ECG recording, ECG Holter monitoring, event-recorder or loop recorder at any time, but before the screening visit
• CHA2DS2-VA risk score ≥2 points
• Left atrial anatomy (atrial septum, pulmonary vein orifices and left atrial appendage) suitable for intervention (PVI + LAAO or LAAO)
• ≥ 4 weeks of adequate anticoagulant treatment in the preceding period
• no anatomical or functional contraindications and patient consent for transesophageal echocardiography (TEE); Based on the aforementioned inclusion criteria, patients who can be classified into 3. groups will be enrolled in the study:
• patients with atrial fibrillation who have been adequately treated with anticoagulation (VKA/NOAC) and have had an ischemic stroke
• patients without prior history of atrial fibrillation and without anticoagulation who have an ischemic stroke and the atrial fibrillation is clinically overt (de novo)
• patients without a prior history of atrial fibrillation, with an initial diagnosis of so-called cryptogenic stroke, in whom further initial ECG monitoring allowed for the detection of clinically silent atrial fibrillation

Ki nem vehet részt

• indication for chronic anticoagulant treatment independent of AF:; history of mechanical valve implantation; history of mitral biological valve implantation within 3 months prior to randomization; history of deep vein thrombosis or pulmonary embolism within preceding 6 months or indication for chronic anticoagulation; genetically or immunologically confirmed thrombophilia
• major bleeding as defined by ISTH within 14 days prior to randomization or intracranial bleeding ever
• history of myocardial infarction with or without intervention within 90 days prior to randomization
• Ischemic stroke of etiology other than AF, including cryptogenic stroke without evidence of AF etiology
• history of PVI or LAAO implantation
• history of surgical closure of left atrial appendage
• history of percutaneous or surgical ASD/PFO closure
• cardiac tamponade
• chronic heart failure in NYHA functional class IV
• Child-Pugh class B or C chronic liver failure
• severe valvular heart defect
• contraindications to NOAC treatment:; eGFR ≤15 ml/min/1.73 m2; mechanical valve prosthesis; moderate or severe mitral valve stenosis of rheumatic etiology; life-threatening bleeding during NOAC therapy
• left ventricular ejection fraction (LVEF) <30%
• chronic kidney disease stage IV-V (eGFR <30 ml/min/1.73 m2)
• active infection, defined as CRP >30 mg/dL with symptoms of respiratory, urinary or gastrointestinal tract infection
• age <18 or >80 years
• documented life expectancy < 4 years
• active cancer < 5 years after remission
• current participation in another clinical trial
• lack of informed written consent to participate in the study
• valvular AF: presence of moderate to severe aortic stenosis of rheumatic etiology
• permanent AF
• persistent long-standing AF (>1 year)
• presence of a thrombus in the left atrial appendage on TEE examination
• significant psychomotor dysfunction defined as a modified Rankin Scale (mRS) score of 4-6 or NIHSS score ≥16
• active hyperthyroidism
• acute or chronic pericarditis
• lack of vascular access for PVI and LAAO implantation
• body mass index (BMI, body mass index) ≥40 kg/m2
• woman in her childbearing years planning a pregnancy
• pregnancy or lactation period