Paroxysmal atrial fibrillation
Conditions
Interventions
single arm:Treatment of atrial fibrillation using Lepu Medical Electric Cryoablation System
Sponsors
Beijing Anzhen Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age = 18 years old = 80 years old, regardless of gender; 2. Symptomatic paroxysmal atrial fibrillation patients who have taken at least one type I or III antiarrhythmic drug with poor treatment effect, are unable to tolerate drug treatment, or are unwilling to take antiarrhythmic drugs; 3. Suitable for cryoablation treatment; 4. The subject is able to understand the purpose of the experiment and complete informed consent.
Exclusion criteria
Exclusion criteria: 1. Have a history of left atrial ablation or left atrial surgery in the past; 2. Evidence showing left atrial thrombosis; 3. Patients with pulmonary vein stenosis or pulmonary vein stent implantation; 4. Patients with phrenic nerve paralysis on either side; 5. Left atrial anteroposterior diameter = 50mm; 6. NYHA cardiac function grading = Level III or left ventricular ejection fraction (LVEF)30 seconds) confirmed by electrocardiogram before surgery; 9. Those who plan to undergo left atrial appendage closure surgery at the same time; 10. Individuals with a history of severe structural heart disease, including severe valve insufficiency or stenosis, congenital heart disease, and hypertrophic cardiomyopathy; 11. Those who have implanted artificial heart valves before surgery or plan to undergo transcatheter aortic valve implantation (TAVI) treatment within 3 months after surgery; 12. Those who have had myocardial infarction within 3 months before surgery, or have undergone percutaneous coronary intervention (PCI)/percutaneous transluminal coronary angioplasty (PTCA), or have undergone coronary artery bypass grafting; 13. Have experienced cerebral ischemia events within 6 months before surgery (excluding asymptomatic lacunar cerebral infarction); 14. Patients with severe liver and kidney dysfunction (GFR<30mL/min • 1.73m2); 15. Individuals with a history of contrast agent allergy or inability to tolerate heparinization; 16. Individuals with a previous history of cryoglobulinemia; 17. Pregnant or lactating women; 18. Those with an expected lifespan of less than 1 year; 19. Those who are participating in clinical trials of any other drug, device, or biological agent but have not reached the main evaluation endpoint; 20. Those who are unwilling or unable to fully comply with the research protocol and complete follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Success rate of pulmonary vein isolation (PVI);Treatment Success Rate;Recurrence rate of atrial arrhythmias;The incidence of re treatment due to recurrence of atrial tachyarrhythmia;The incidence of surgical related complications;Device performance evaluation;EQ-5D Quality of Life Score; | — |
Countries
China
Contacts
Public ContactTang Ribo
Lepu Medical Electronic Instrument Co., Ltd. Beijing Anzhen Hospital Affiliated to Capital Medical University
Outcome results
None listed