paroxysmal atrial fibrillation
Conditions
Interventions
General Anesthesia Group:general anesthesia
Conscious Sedation Group:conscious sedation
Sponsors
Beijing Anzhen Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Age: 18 - 80 years old; 2.Paroxysmal atrial fibrillation; 3.No history of catheter ablation for atrial fibrillation or atrial flutter; 4.Intending to undergo pulsed electric field ablation; 5.Agree to participate in the study and sign the informed consent form, and be able to cooperate with the follow-up;
Exclusion criteria
Exclusion criteria: 1. Obstructive sleep apnea-hypopnea syndrome (OSAHS); 2. Concurrent severe chronic obstructive pulmonary disease (COPD), asthma, or other respiratory diseases; 3. Body mass index (BMI) > 30 kg/m^2 or = 4); 7. Current left ventricular ejection fraction (LVEF) <= 40% or New York Heart Association (NYHA) functional class III-IV; 8. Acute coronary syndrome within the past 3 months; 9. Percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), or other cardiac/vascular surgery within the past 3 months; 10. Moderate or severe aortic or mitral valve stenosis or severe regurgitation; 11. Acute cerebrovascular disease within the past 1 month; 12. Severe liver dysfunction (Child-Pugh class C); 13. Estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m^2 or dialysis-dependent status; 14. History of chronic heavy alcohol consumption; 15. History of substance abuse; 16. Allergy to any medications used in the study protocol; 17. Pregnancy or breastfeeding; 18. Current participation in other interventional clinical trials; 19. Presence of any condition deemed by the investigator to make the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A composite outcome : (1) Systolic blood pressure persistently below 85 mmHg for more than 60 sec; or (2) Persistent hypoxemia (SpO? < 85%) for more than 60 seconds.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Operational sedation quality; invasive arterial blood pressure;fluoroscopy time;Score for the difficulty of maintaining composure;PaCO2 in blood gas immediately before discontinuing sedative/hypnotic drugs;X-ray fluoroscopy dose;The duration of catheter staying in the left atrium;Immediate isolation rate;Atrial fibrillation occurred 30 days after the surgery;serious adverse event;Atrail fibrillation burden 90 days after the surgery.;The number of occurrences of each component of the primary outcome;Total operation time;Total ablation time;Atrail fibrillation recurred 90 days after the surgery.;Total number of ablations; | — |
Countries
China
Contacts
Public ContactNing Zhou
Beijing Anzhen Hospital, Capital Medical University
Outcome results
None listed