Paroxysmal atrial fibrillation
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age =18 years, regardless of gender. 2.Diagnosed with paroxysmal atrial fibrillation and scheduled for catheter radiofrequency ablation. 3.The subject or their legally authorized representative is able to understand the study purpose, voluntarily agrees to participate by providing written informed consent, and is willing to complete all required follow-ups as per the protocol.
Exclusion criteria
Exclusion criteria: 1.Severe heart failure (New York Heart Association Class IV); 2.Myocardial infarction or unstable angina within 1 month prior to enrollment. 3.Active bleeding or uncorrected coagulation disorders (defined as: platelet count 2 times the upper limit of normal). 4.Leukopenia (WBC 3 times the upper limit of normal). 6.Renal insufficiency (serum creatinine =3.5 mg/dL) or requiring dialysis. 7.Presence of intracardiac thrombus, tumor, or vegetation. 8.Severe structural heart disease deemed by the investigator to potentially interfere with the procedure (e.g., severe mitral, tricuspid, or aortic valve deformity; Tetralogy of Fallot; transposition of the great arteries, etc.). 9.Absence of inferior vena cava, or presence of thrombus/severe stenotic-occlusive disease in the interventional access route. 10.Hemodynamic instability or critically ill condition requiring emergency surgery. 11.Presence or suspicion of infective endocarditis or systemic active infection. 12.Participation in another clinical trial within 3 months prior to enrollment or current participation in another drug/device clinical trial without having reached its primary endpoint. 13.Pregnancy, lactation, plan for pregnancy within 1 year, or unwillingness to use effective contraception. 14.Any other condition considered by the investigator to make the subject unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the first pass isolation rate of pulmonary veins; | — |
Secondary
| Measure | Time frame |
|---|---|
| the rate of steam pops; | — |
Countries
China
Contacts
The First Affiliated Hospital of Ningbo University