Safety and Efficacy of Very High-Power Short-Duration Radiofrequency Ablation With Half-Normal Saline Irrigation for Pulmonary Vein Isolation

Prior treatment

• Patients with myocardial infarction or unstable angina within 1 month prior to enrollment.
• Participation in another clinical trial within 3 months prior to enrollment, or current participation in another drug/device clinical trial without having reached the primary endpoint.

Other illness

• Patients with severe heart failure (NYHA Class IV).
• Severe structural heart disease deemed by the investigator as potentially interfering with the procedure (e.g., severe mitral, tricuspid, or aortic valve deformity, tetralogy of Fallot, transposition of the great arteries, etc.).
• Hemodynamically unstable patients or those in critical condition requiring emergency surgery.
• Presence or suspicion of infective endocarditis or systemic active infection.
• Any other condition considered by the investigator as unsuitable for participation.

Lab values

• Presence of active bleeding, or uncorrected coagulation abnormalities (platelet count \<50×10⁹/L or APTT \>2 times the upper limit of normal).
• Leukopenia (WBC \<3×10⁹/L) or acute anemia (Hb \<90 g/L).
• Hepatic insufficiency (ALT or AST \>3 times the upper limit of normal).
• Renal insufficiency (serum creatinine ≥3.5 mg/dL), or patients requiring dialysis.

Other

• Presence of intracardiac thrombus, tumor, or vegetation.
• Absence of the inferior vena cava, or presence of thrombus, severe stenotic/occlusive lesions in the interventional access route.
• Pregnant or lactating women, individuals planning pregnancy within 1 year, or those unwilling to use effective contraception.

• Age ≥ 18 years, both male and female participants are eligible.
• Diagnosis of paroxysmal atrial fibrillation and scheduled for catheter radiofrequency ablation.
• The subject or their legal guardian is capable of understanding the study purpose, voluntarily agrees to participate by providing written informed consent, and is willing to complete the follow-up as required by the protocol.