Pulsed Field Ablation Using a Novel Biphasic Catheter vs Thermal Ablation for Paroxysmal Atrial Fibrilation:InsightPFA Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 292
- 试验地点
- 10
- 主要终点
- the 12-month treatment success rate
研究概览
简要总结
This trial aims to determine whether the InsightPFA for PVI is as effective and safe as standard RFA in the treatment of symptomatic paroxysmal AF.
详细描述
The InsightPFA trial is a prospective, multicenter, randomized controlled trial to compare the effectiveness and safety of PFA versus RFA for PVI in Chinese patients with symptomatic paroxysmal AF. Two hundred and ninety-two patients diagnosed with symptomatic paroxysmal AF will be randomly assigned to either the PFA group or the RFA group in a 1:1 ratio. All subjects will undergo PVI using PFA or AI guided RFA and be followed up to 12 months. The primary endpoint is defined as freedom from any episodes of AF/AFL/AT without Class I or III antiarrhythmic drugs during the 9-month follow-up period after a 90-day blank period. The secondary endpoints of effectiveness include acute treatment success and procedural data. The safety evaluation includes a composite of death, stroke and transient ischemic attack, procedure-related complications, device-related adverse events, and serious adverse events. A noninferiority comparison will be conducted between the novel PFA system and the existing RFA system in terms of both effectiveness and 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 75 years, of either sex.
- •Patients with ECG-confirmed or clinically definite diagnosis of symptomatic paroxysmal atrial fibrillation (PAF).
- •Scheduled to undergo catheter ablation for atrial fibrillation
- •Willing to participate in this clinical trial, voluntarily sign the informed consent form, and commit to completing required examinations and follow-ups per protocol..
排除标准
- •History of prior surgery or catheter ablation for atrial fibrillation (AF);
- •Clinical diagnosis of persistent or long-standing persistent AF;
- •Left ventricular ejection fraction (LVEF) < 40% or New York Heart Association (NYHA) functional class III or IV;
- •Left atrial diameter (as measured by echocardiography) ≥ 50 mm;
- •Imaging findings suggestive of left atrial or left atrial appendage thrombus;
- •Contraindications to anticoagulation therapy, including a history of blood clotting disorders or abnormal bleeding;
- •Presence of acute or active systemic infection;
- •Significant lung disease, pulmonary hypertension, or any lung condition associated with severe dyspnea, such as abnormal blood gases;
- •Clinical diagnosis of hypertrophic cardiomyopatly, chronic obstructive pulmonary disease (COPD), or known/suspected atrial myxoma;
- •History of previous heart valve repair or replacement, implantation of a prosthetic valve, or previous cardiac interventions such as atrial septal defect closure or patent foramen ovale closure;
- •Presence of an implanted cardioverter defibrillator or other active implanted devices;
- •Myocardial infarction, unstable angina, or any cardiac intervention/open surgery (excluding coronary angiography) within the past 3 months; hospitalization for heart failure, stroke (excluding silent stroke), or transient ischemic attack within the past 3 months;
- •Any carotid stenting or endarterectomy performed within the past 6 months;
- •Patients who have clear contraindications to interventional procedures, rendering them unsuitable for the ablation procedure in the judgment of the investigator;
- •Participation in other drug or device clinical trials concurrently;
- •Life expectancy of less than 12 months due to conditions such as advanced malignancy;
- •Women who are pregnant, breastfeeding, or planning to conceive during the trial period;
- •Any other situations deemed inappropriate for participation in the clinical trial as determined by the investigator
结局指标
主要结局
the 12-month treatment success rate
时间窗: during the 12-month follow-up period after a 90-day blank period.
12month treatment success, is defined as freedom from any episodes of AF/atrial flutter (AFL)/atrial tachycardia (AT) without the use of Class I or III antiarrhythmic drugs (AADs) during the 12-month follow-up period after a 90-day blank period. An electrocardiogram or 24 h Holter monitoring should be performed to confirm all episodes. The occurrence of AF/AFL/AT during a blank period is not considered a treatment failure and can be treated with AADs (other than amiodarone), electric cardioversion, or only a time of catheter ablation procedure (the devices used during the redo procedure should be the same as those used in the original procedure). After the blanking period, any documentation of AF, AFL, or AT ≥ 30 s is considered a failure concerning the primary effectiveness endpoint. Following the blanking period, any use of a Class I or III AAD constitutes a treatment failure.
次要结局
- Total left atrium indwelling time(During the procedure)
- Total abaltion time(During the procedure)
- Total X-ray exposure time(During the procedure)
- Total X-ray exposure dose(During the procedure)
- Number of participants under general anesthesia(During the procedure)
- incidence of surgical complications(12 months after the ablation)
- Acute procedural success(after a 20 min observation period following the last ablation.)
- Total procedure time(During the procedure)
- Evaluation of the ablation system（questionnaire）(immediately post ablation)
- Evaluation of the ablation catheter（questionnaire）(immediately post ablation)
- Evaluation of the adjustable introducer sheath set（questionnaire）(immediately post ablation)
- incidence of composite safety endpoint(12 months after the ablation)
- Incidence of severe adverse events(12 months after the ablation)
- Incidence of device-related adverse events(12 months after the ablation)