Efficacy and Safety of Pulsed Field Ablation in the Treatment of Ventricular Arrhythmias
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Immediate Procedural Success Rate
研究概览
简要总结
This is a prospective, single-center, single-arm exploratory clinical study designed to evaluate the efficacy and safety of pulsed field ablation for the treatment of ventricular arrhythmias.
Approximately 30 patients with ventricular arrhythmias who have an indication for catheter ablation and are scheduled to undergo pulsed field ablation will be enrolled. Eligible participants may include patients with frequent premature ventricular contractions, sustained monomorphic ventricular tachycardia, or a history of malignant ventricular arrhythmias with an indication for catheter ablation.
All participants will undergo pulsed field ablation using a disposable magnetic navigation and contact force-sensing pulsed field ablation catheter. The study will assess immediate procedural success, treatment success at 6 months after ablation, procedural characteristics, quality of life, and adverse events or serious adverse events during the study period.
详细描述
Ventricular arrhythmias include frequent premature ventricular contractions, sustained ventricular tachycardia, ventricular flutter, and ventricular fibrillation. Catheter ablation is an important treatment option for selected patients with ventricular arrhythmias. Pulsed field ablation is a non-thermal ablation technology that may achieve myocardial tissue ablation through irreversible electroporation and may reduce thermal injury to surrounding tissues.
This study is a prospective, single-center, single-arm exploratory clinical study. Approximately 30 patients with ventricular arrhythmias who have an indication for catheter ablation and are scheduled to undergo pulsed field ablation will be enrolled. The study aims to preliminarily evaluate the acute and 6-month effectiveness of pulsed field ablation, as well as its procedural safety profile.
The investigational procedure will be performed using a disposable magnetic navigation and contact force-sensing pulsed field ablation catheter. The ablation target site, ablation strategy, and procedural endpoint will be determined by the investigator according to the type and origin of the ventricular arrhythmia, electroanatomical mapping findings, and standard clinical practice.
The primary outcomes are immediate procedural success and treatment success at 6 months after ablation. Immediate procedural success will be assessed at the end of the ablation procedure. Treatment success at 6 months will be evaluated through clinical follow-up, standard electrocardiography, Holter monitoring, device interrogation when applicable, and investigator assessment.
Secondary outcomes include procedure time, pulsed field ablation delivery time and number of applications, ablation site information, fluoroscopy time, quality of life assessed using EQ-5D-5L and SF-36, death, stroke or transient ischemic attack, procedure-related complications, pulsed field energy-related complications, and other adverse events or serious adverse events during the study period.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must meet all of the following criteria:
- •Age 18 to 75 years, inclusive.
- •Diagnosis of ventricular arrhythmia with an indication for catheter ablation, and scheduled to undergo pulsed field ablation, meeting one of the following conditions:
- •Frequent premature ventricular contractions, defined as a premature ventricular contraction burden greater than 10% of total heartbeats on 24-hour Holter monitoring;
- •Sustained monomorphic ventricular tachycardia;
- •History of malignant ventricular arrhythmias, including sustained polymorphic ventricular tachycardia, ventricular flutter, or ventricular fibrillation, with an indication for catheter ablation.
- •For participants with an indication for implantable cardioverter-defibrillator implantation, the participant has already received an implantable cardioverter-defibrillator or agrees to undergo implantable cardioverter-defibrillator implantation in the near future.
- •Able and willing to provide written informed consent and comply with all study follow-up requirements.
排除标准
- •Presence of atrial arrhythmias before the procedure that cannot be treated using the study device.
- •Ventricular arrhythmias caused by electrolyte disturbance, reversible causes, or non-cardiac causes.
- •Severe left ventricular enlargement, defined as left ventricular anteroposterior diameter greater than 80 mm.
- •Left ventricular ejection fraction of 35% or less.
- •New York Heart Association functional class III or IV.
- •Previous cardiac surgery, including patent foramen ovale closure, left atrial appendage closure, cardiac valve repair or replacement, or other cardiac surgery that makes the participant unsuitable for catheter ablation.
- •Significant congenital cardiac anatomical abnormalities that prevent the ablation catheter from accessing the target ablation area.
- •Planned cardiac surgery or other major surgery within the next 12 months that may affect ablation treatment, including heart transplantation, left atrial appendage closure, or patent foramen ovale closure.
- •Intracardiac thrombus, myxoma, occlusion device, or other condition that may interfere with catheter insertion or manipulation.
- •Severe vascular access obstruction, such as an implanted inferior vena cava filter or mural thrombus.
- •Uncontrolled hypertension, defined as persistent systolic blood pressure of 180 mmHg or higher or persistent diastolic blood pressure of 110 mmHg or higher.
- •Severe restrictive or obstructive pulmonary disease or chronic respiratory disease that, in the investigator's judgment, makes the participant unsuitable for cardiac intervention.
- •Obvious bleeding tendency or hematologic disease.
- •Untreated or uncontrolled hyperthyroidism or hypothyroidism.
- •Acute or severe systemic active infection, significant hepatic or renal dysfunction defined as ALT, AST, or creatinine greater than twice the upper limit of normal, malignancy, or end-stage disease.
- •Unstable angina or acute myocardial infarction within 3 months before enrollment.
- •Percutaneous coronary intervention or coronary artery bypass grafting within 3 months before enrollment.
- •Stroke or transient ischemic attack within 3 months before enrollment.
- •Thromboembolic disease.
- •Clear contraindication to interventional procedures or ablation as determined by the investigator.
- •Pregnancy, lactation, or planned pregnancy during the study period.
- •Participation in another drug or medical device clinical trial within 3 months before enrollment.
- •Any condition that, in the investigator's judgment, makes the participant unsuitable for participation in this clinical study.
结局指标
主要结局
Immediate Procedural Success Rate
时间窗: At the end of the ablation procedure, after a 30-minute post-ablation observation period
Immediate procedural success is defined as meeting either of the following criteria after ablation: (1) disappearance of the clinical ventricular arrhythmia, with no reinduction by pharmacological provocation and/or programmed electrical stimulation after a 30-minute observation period; or (2) a reduction of at least 80% in the number or duration of abnormal ventricular beats compared with the pre-ablation baseline, maintained during the 30-minute observation period and after pharmacological provocation and/or programmed electrical stimulation.
Treatment Success Rate at 6 Months After Ablation
时间窗: 6 months after ablation
Treatment success at 6 months after ablation is defined as disappearance of the clinical ventricular arrhythmia on follow-up Holter monitoring; or at least an 80% reduction in the number or duration of abnormal ventricular beats compared with baseline Holter monitoring. The assessment will be based on clinical follow-up, standard electrocardiography, Holter monitoring, device interrogation when applicable, and investigator assessment.
次要结局
- Total Procedure Time(During the ablation procedure)
- Total Pulsed Field Ablation Delivery Time(During the ablation procedure)
- Number of Pulsed Field Ablation Applications(During the ablation procedure)
- Percentage of Participants With Death, Stroke, or Transient Ischemic Attack(From enrollment through 6 months after ablation)
- Percentage of Participants With Procedure-Related Complications(From the ablation procedure through 6 months after ablation)
- Percentage of Participants With Pulsed Field Ablation-Related Complications(From the ablation procedure through 6 months after ablation)
- Change From Baseline in EQ-5D-5L Index Score(Baseline, 3 months, and 6 months after ablation)
- Change From Baseline in SF-36 Score(Baseline, 3 months, and 6 months after ablation)
研究者
Hongtao Wang
Associate Professor
Xi'an Jiaotong University