Safety and Efficacy of Very High-Power Short-Duration Radiofrequency Ablation With Half-Normal Saline Irrigation for Pulmonary Vein Isolation: A Prospective，Single-center Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- The efficacy of the Very High-Power Short-Duration (vHPSD) ablation mode with half-normal saline irrigation
研究概览
简要总结
Primary Objective: To evaluate the efficacy of the Very High Power Short Duration (vHPSD) ablation mode with half-normal saline irrigation in achieving pulmonary vein isolation (PVI) for atrial fibrillation, by comparing the single-procedure acute pulmonary vein isolation success rate.
Secondary Objective: To assess the safety of the vHPSD ablation mode with half-normal saline irrigation in PVI for atrial fibrillation, by comparing the incidence of steam pops (POPs).
Study Significance This study aims to address the current limitation of insufficient lesion formation in the anterior left atrial wall when using a uniform 90W/4s ablation strategy with normal saline irrigation. By segmenting the left atrium, different irrigation protocols will be applied: 90W/4s ablation with normal saline irrigation will be performed in the posterior area of left atrium, while 90W/4s ablation with half-normal saline irrigation will be performed in the anterior area of left atrium. This approach is anticipated to enhance the procedural immediate success rate (measured by the rate of acute, first-pass PVI), improve overall procedural efficiency, and ensure procedural safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- (1) Age ≥ 18 years, both male and female participants are eligible. (2) Diagnosis of paroxysmal atrial fibrillation and scheduled for catheter radiofrequency ablation.
- •(3) 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.
排除标准
- •(1) Patients with severe heart failure (NYHA Class IV);
- •(2) Patients with myocardial infarction or unstable angina within 1 month prior to enrollment;
- •(3) Presence of active bleeding, or uncorrected coagulation abnormalities (platelet count <50×10⁹/L or APTT >2 times the upper limit of normal);
- •(4) Leukopenia (WBC <3×10⁹/L) or acute anemia (Hb <90 g/L);
- •(5) Hepatic insufficiency (ALT or AST >3 times the upper limit of normal);
- •(6) Renal insufficiency (serum creatinine ≥3.5 mg/dL), or patients requiring dialysis;
- •(7) Presence of intracardiac thrombus, tumor, or vegetation;
- •(8) 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.);
- •(9) Absence of the inferior vena cava, or presence of thrombus, severe stenotic/occlusive lesions in the interventional access route;
- •(10) Hemodynamically unstable patients or those in critical 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 the primary endpoint;
- •(13) Pregnant or lactating women, individuals planning pregnancy within 1 year, or those unwilling to use effective contraception;
- •(14) Any other condition considered by the investigator as unsuitable for participation.
研究组 & 干预措施
Half-SALINE
Ablation of the left atrial posterior wall will be performed using 90W/4s applications with normal saline irrigation, while ablation of the left atrial anterior wall will be performed using 90W/4s applications with half-normal saline irrigation.
干预措施: vHPSD Ablation with Half-Normal Saline (Procedure)
Normal SALINE
Ablation of both the anterior and posterior walls of the left atrium around the pulmonary veins using 90W/4s model with normal saline irrigation throughout the entire procedure.
干预措施: vHPSD Ablation with Normal Saline (Procedure)
结局指标
主要结局
The efficacy of the Very High-Power Short-Duration (vHPSD) ablation mode with half-normal saline irrigation
时间窗: During ablation procedure
To evaluate the efficacy of the Very High-Power Short-Duration (vHPSD) ablation mode with half-normal saline irrigation in achieving pulmonary vein isolation for atrial fibrillation, by comparing the rate of first-pass isolation.
次要结局
- The safety of the Very High-Power Short-Duration (vHPSD) ablation mode with half-normal saline irrigation(During ablation procedure)