Atrial fibrillation
Conditions
Interventions
Experimental group:For the interatrial septum puncture, an 8.5F adjustable curved sheath tube (Navigo) and an AccuSafe puncture guidewire are used.
Control group:For the interatrial septum puncture, an 8.5F adjustable curved sheath tube (Navigo) and a 98-cm puncture needle (AKS) are used.
Sponsors
ShangHai East Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. The patient's age is within the range of 18 years old (inclusive) to 80 years old (inclusive). 2. There is a definite diagnosis of atrial fibrillation, and the patient has the indications for catheter ablation of atrial fibrillation. 3. The patient is capable of understanding the purpose of the trial and is willing to undergo the evaluations as required by the protocol. 4. The patient consents to participate in this clinical trial and is able to sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with an expected lifespan of less than 1 year due to non-cardiovascular factors. 2. Atrial fibrillation episodes are reversible (such as electrolyte disorders, uncontrolled hyperthyroidism, vasovagal reflexes, etc.). 3. A history of previous atrial fibrillation ablation. 4. The left atrial diameter is >= 55 mm. 5. Patients who have undergone interatrial septum puncture, surgery, patch repair, or patent foramen ovale occlusion. 6. A history of previous heart transplantation, complex congenital heart disease, or rheumatic heart disease. 7. Patients with inferior vena cava stenosis or absence. 8. Those with contraindications to radiofrequency ablation, anti-arrhythmic drugs, or anticoagulant drugs. 9. Patients who have had an acute coronary syndrome, a history of cardiac surgery, angioplasty, or cerebrovascular accident within 12 weeks before enrollment. 10. Severe hepatic and renal insufficiency. 11. BMI > 50 kg/m². 12. Pregnant or lactating women. 13. Any situation that the investigator deems may prevent the patient from completing the study. 14. Patients who are currently participating in other clinical studies of drugs or medical devices.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time (in minutes) of transseptal puncture (TSP); | — |
Secondary
| Measure | Time frame |
|---|---|
| First puncture success rate;Adverse events associated with atrial septal puncture;The exposure time and dose of X-ray during atrial septal puncture;The usage amount of contrast agent during the atrial septal puncture procedure;Number of atrial septal punctures;The number of device exchanges;Precise atrial septal puncture;Other observation indicators (total operation time, contrast agent usage, X-ray fluoroscopy time and dose); | — |
Countries
China
Contacts
Public ContactYang Bing
Shanghai East Hospital
Outcome results
None listed