NCT07079813尚未招募不适用
Clinical Study on the Efficiency of Rapid Arrhythmia Mapping Using EasyStars™ High Density Mapping Catheter Applications
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 主要终点
- primary efficacy endpoint
研究概览
简要总结
The primary objective of this study was to evaluate the clinical feasibility, safety, and surgical characteristics of the EasyStars™ High Density Mapping Catheterin in patients with complex arrhythmias.
详细描述
The primary objective of this study was to evaluate the clinical feasibility, safety, and surgical characteristics of the EasyStars™ High Density Mapping Catheterin in patients with complex arrhythmias. In addition, the study assessed the catheter's usability and mapping performance through postoperative physician feedback.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis: Ventricular tachycardia (VT)
- •Inclusion criteria:
- •Patients aged between 18 and 80 years;
- •Confirmed diagnosis of ventricular tachycardia (VT) via electrocardiogram (ECG) or 24-hour Holter monitoring;
- •The patient has experienced at least one episode of VT in the past 6 months and exhibits symptoms of sustained or paroxysmal ventricular tachycardia;
- •The patient meets the criteria for ablation surgery and has clear indications for ablation;
- •The patient is in good general health and able to tolerate surgery (no severe underlying heart disease, such as severe heart failure or severe coronary artery disease);
- •Voluntarily participates and signs an informed consent form.
排除标准
- •Uncontrolled heart failure (New York Heart Association functional class III-IV);
- •History of acute or progressive myocardial infarction;
- •Severe pulmonary, hepatic, or renal disease;
- •Valvular heart disease or congenital heart disease;
- •Excessive use of medications or medication intolerance (e.g., beta-blockers, antiarrhythmic drugs);
- •Clinical diagnosis: Atrial tachycardia (AT)
- •Inclusion criteria:
- •Patients aged 18 to 80 years;
- •Diagnosed with atrial tachycardia (AT) by electrocardiogram (ECG) or Holter monitoring;
- •Patients presenting with clinical symptoms such as palpitations, chest tightness, or fatigue;
- •Patients diagnosed with persistent or paroxysmal atrial tachycardia and meeting the criteria for ablation therapy;
- •Patients who voluntarily participate and sign an informed consent form.
- •Exclusion criteria:
- •Patients with severe valvular heart disease or congenital heart disease;
- •Patients with severe left ventricular or right ventricular heart failure;
- •Patients with severe systemic diseases, such as liver failure, kidney failure, or tumours;
- •Patients with cardiomyopathy or aortic dissection;
- •Clinical diagnosis: atypical atrial flutter (AFL)
- •Inclusion criteria:
- •Patients aged 18 to 80 years;
- •Patients diagnosed with atypical atrial flutter (AFL) via electrocardiogram (ECG) or Holter monitoring;
- •Patients with clinical symptoms (e.g., palpitations, chest tightness, fatigue, etc.) that significantly impair their quality of life;
- •Patients who meet the criteria for atrial tachycardia ablation and have no other severe comorbidities;
- •Voluntarily participate and sign an informed consent form.
- •Exclusion criteria:
- •Patients with severe heart disease, such as cardiomyopathy or severe valvular disease;
- •Patients with severe pulmonary disease, such as pulmonary arterial hypertension;
- •Patients with a history of major cardiac surgery (e.g., heart transplantation);
- •Clinically diagnosed with paroxysmal atrial fibrillation (PAF)
- •Inclusion criteria:
- •Patients aged 18 to 80 years;
- •Diagnosed with paroxysmal atrial fibrillation (PAF) via electrocardiogram (ECG) or Holter monitoring;
- •Frequent episodes of paroxysmal atrial fibrillation with symptoms such as palpitations, fatigue, and dyspnoea, and meeting the criteria for ablation;
- •No other severe cardiac or systemic diseases, and meeting the criteria for ablation;
- •Voluntarily participating and signing the informed consent form.
- •Exclusion criteria:
- •Patients with severe valvular heart disease, aortic dissection, or cardiomyopathy;
- •High-risk patients with a history of anticoagulant therapy or currently receiving anticoagulant therapy (e.g., history of thrombosis or stroke);
- •Patients with severe underlying conditions such as cancer or severe diabetes;
- •Clinical diagnosis: Persistent atrial fibrillation (PsAF)
- •Inclusion criteria:
- •Patients aged 18 to 80 years;
- •Diagnosed with persistent atrial fibrillation (PsAF) via electrocardiogram (ECG) or Holter monitoring;
- •Atrial fibrillation persisting for more than 7 days and symptoms affecting the patient's quality of life;
- •Clear indications for ablation and no other severe comorbidities;
- •Voluntarily participating and signing an informed consent form.
- •Exclusion criteria:
- •Presence of severe valvular heart disease or cardiomyopathy;
- •History of stroke or clinical evidence of thrombus formation;
- •Severe heart failure (NYHA III-IV class);
- 另有 1 项未显示
结局指标
主要结局
primary efficacy endpoint
时间窗: On the day of the surgery
The proportion of immediate success (all participating subjects) in treating rapid arrhythmias using EasyStars™ High Density Mapping Catheter in combination with cardiac ablation catheters and three-dimensional cardiac electrophysiology mapping systems
primary efficacy endpoint
时间窗: On the day of the surgery
The proportion of immediate success (all participating subjects) in treating rapid arrhythmias using EasyStars™ High Density Mapping Catheter in combination with cardiac ablation catheters and three-dimensional cardiac electrophysiology mapping systems
次要结局
未报告次要终点
研究者
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