atrial fibrillation
Conditions
Interventions
Single group :Regular follow-up after implantation of experimental instruments
Sponsors
The First Affiliated HospitalCollege of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Patients should meet all the following inclusion criteria before being enrolled in this trial: 1. age = 18 years old, = 80 years old, male or non pregnant female patients; 2. the patient or his guardian was informed of the nature of the trial and agreed to participate in all the terms of the trial, voluntarily signed the informed consent approved by the ethics committee, agreed to accept the postoperative treatment plan and follow-up requirements, and was able to complete the follow-up and follow-up inspection requirements; 3. patients with ECG confirmed history of atrial fibrillation (paroxysmal, persistent or long-term persistent atrial fibrillation); 4. Cha2ds2 VASC score = 2; (Appendix 2) 5. Has-bled score = 2; (Appendix 3) 6. LVEF > 50%; 7. patients with atrial fibrillation or those who need to undergo one of the following conventional open heart surgery at the same time, including mitral valve replacement, aortic valve replacement, and coronary artery bypass grafting; 8. patients with at least 1-year survival expectation;
Exclusion criteria
Exclusion criteria: Patients will not be enrolled in this trial if they meet any of the following conditions: clinical diagnosis 1 Patients with myocardial infarction within 60 days before operation; 2. heart failure patients with cardiac function grade IV (NYHA); (Appendix 4) 3. patients with stroke within 30 days or transient ischemic attack (TIA) within 3 days; 4. patients with a history of cardiac surgery or suspected pericardial adhesions; 5. patients with active infection, sepsis or fever of unknown cause; 6. patients with active endocarditis and vegetations in the heart; 7. patients with pericarditis or history of pericardial puncture; 8. patients with cardiac tumors or tumors in other parts with an expected life expectancy of less than 1 year; laboratory examination 1. Hematological abnormalities (white blood cell WBC35 Related to surgery/instruments 1. Patients with a history of left atrial appendage intervention; 2. Postoperative patients with implantable heart rate defibrillators (ICDs); 3. Individuals with a history of catheter ablation with perforation or complications; 4. Individuals with a history of percutaneous coronary intervention perforation; 5. Individuals with a history of cardiac or thoracic surgery within 30 days prior to surgery; 6. Patients who plan to undergo atrial arrhythmia ablation surgery within 6 months after surgery; 7. Planned electroconversion within 6 months after surgery; 8. Patients who plan to receive surgical treatment for structural heart disease within 6 months; 9. Patients after heart transplantation; 10. Patients who are allergic or contraindicated to metal nickel titanium alloys, aspirin, clopidogrel, or heparin; Ultrasound exclusion criteria 1. patients who are unable or unwilling to accept intraoperative transesophageal echocardiography (TEE); 2. echocardiographic measurement of left atrial appendage root diameter = 29 mm or = 50 mm; 3. thrombus in left atrium (LA) or left atrial appendage (LAA) according to TTE; 4. there is obvious and unexplained pericardial effusion (low to medium volume); 5. left atrial anteroposterior diameter = 6cm; 6. patients with carotid stenosis more than 60% of the diameter; 7. symptomatic patients with carotid stenosis; 8. patients with bilateral carotid stenosis > 50%;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of no device related serious adverse events;The complete closure rate of left atrial appendage; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of cardiovascular death ;Incidence of myocardial infarction;Incidence of serious damage to heart structure or other body structure related to the test device;Incidence of major bleeding;Incidence of stroke and non central nervous system embolism;Complete closure rate of left atrial appendage during operation;Device technology success rate;Adverse event occurrence rate; | — |
Countries
China
Contacts
Public ContactNi Yiming
the First Affiliated HospitalCollege of Medicine, Zhejiang University
Outcome results
None listed