Status:
NOT_YET_RECRUITING
Complex Percutaneous Pulmonary Vein Isolation Combined With Left Atrial Appendage Occluder Implantation for Patients With Cardiogenic Ischemic Stroke in the Course of Atrial Fibrillation
Lead Sponsor:
Medical University of Silesia
Collaborating Sponsors:
Leszek Giec Upper-Silesian Medical Centre of the Medical University of Silesia
Silesian Center for Heart Diseases
Conditions:
Ischemic Stroke
Atrial Fibrillation
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The project is a multicenter, open-label, randomized medical experiment, which was designed to evaluate the efficacy and safety of single-stage pulmonary vein isolation (PVI) and implantation of left ...
Eligibility Criteria
Inclusion
- 1 Status post ischemic stroke within 6-12 weeks of randomization with or without reperfusion therapy, confirmed by imaging studies (CT or MRI) that led to mild to moderate psychomotor dysfunction (mRS 1-3; NIHSS \<16 points) and was treated with early neurological rehabilitation. An obligatory criterion is persistence of symptoms for \>24 h.
- 2\. Diagnosis of paroxysmal or persistent atrial fibrillation made on the basis of 12-lead ECG recording, ECG Holter monitoring, event-recorder or loop recorder at any time, but before the screening visit.
- 3\. CHA2DS-VASc stroke and embolic complications risk scale ≥2 points in men and ≥3 points in women 4. left atrial anatomy (atrial septum, pulmonary vein orifices and left atrial appendage) to allow intervention (PVI + LAAO or LAAO) 5. ≥ 4 weeks of adequate anticoagulant treatment in the preceding period 6. 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 a prior history of atrial fibrillation 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 during further initial observation comes to the detection of clinically silent atrial fibrillation
Exclusion
- current participation in another clinical trial
- Lack of informed written consent to participate in the study
- age \<18 or ≥75 years
- indication for chronic anticoagulant treatment independent of AF:
- status after mechanical valve implantation in any position
- status after implantation of a biological valve in the mitral position within 3 months prior to randomization
- status after a history of deep vein thrombosis or pulmonary embolism
- genetically or immunologically confirmed thrombophilia
- Contraindications to NOAC treatment:
- eGFR ≤15 ml/min/1.73 m2
- valvular heart prosthesis
- moderate or severe mitral valve stenosis of rheumatic etiology
- life-threatening bleeding during NOAC therapy
- Ischemic stroke of etiology other than AF, including cryptogenic stroke without evidence of AF etiology
- valvular AF: presence of moderate to severe aortic stenosis of rheumatic etiology
- persistent AF
- persistent, prolonged (\> 1 year) AF
- 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
- major bleeding as defined by ISTH within 14 days prior to randomization or intracranial bleeding ever
- active hyperthyroidism
- history of myocardial infarction with or without intervention within 90 days prior to randomization
- history of ischemic stroke preceding the current episode
- status after PVI or LAAO implantation
- status after surgical closure of left atrial appendage
- status after percutaneous or surgical ASD/PFO
- symptoms of acute or chronic pericarditis
- symptoms of cardiac tamponade
- lack of vascular access for PVI and LAAO implantation
- chronic heart failure in NYHA functional class IV
- left ventricular ejection fraction (LVEF) \<30%
- chronic kidney disease stage IV-V (eGFR \<30 ml/min/1.73 m2)
- Child-Pugh class B or C chronic liver failure
- severe valvular heart defect
- body mass index (BMI, body mass index) ≥40 kg/m2
- woman in her childbearing years planning a pregnancy
- pregnancy or lactation period
- documented life expectancy \< 4 years
- active cancer \< 5 years after remission
- active infection, defined as CRP \>30 mg/dL with symptoms of respiratory, urinary or gastrointestinal tract infection
Key Trial Info
Start Date :
January 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2029
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT06212674
Start Date
January 31 2024
End Date
August 31 2029
Last Update
January 24 2024
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