ICY-AVNRT (Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 572
- 试验地点
- 68
- 主要终点
- Chronic Safety (Through 6 Months) of the Freezor Xtra Catheter When Used for the Treatment of AVNRT Using an Endocardial Approach.
研究概览
简要总结
ICY-AVNRT (Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia) is a prospective multi-center, nonrandomized, single arm, controlled, unblinded, investigational clinical study. The purpose of this clinical study is to demonstrate the safety and effectiveness of the Freezor® Xtra Cardiac CryoAblation Catheter for the cryoablation of the conducting tissues of the heart in the treatment of patients with atrioventricular nodal reentrant tachycardia (AVNRT) using an endocardial approach.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pre-Electrophysiology Study Inclusion Criteria:
- •Supraventricular tachycardia (SVT) compatible with atrioventricular nodal reentrant tachycardia (AVNRT), documented by ECG, TTM, Holter or event monitor
- •Pre-Electrophysiology Study
排除标准
- •History of sustained (≥30 seconds) of ventricular tachycardia
- •Atrial tachycardia or other arrhythmia that could be confused with AVNRT
- •Reversible cause of SVT
- •History of previous AVNRT ablation
- •Therapy with amiodarone within last 90 days
- •Unstable angina/myocardial infarction/open heart surgery in past 60 days
- •New York Heart Association (NYHA) Classification III or IV currently or within the past 90 days
- •Implantable cardiac rhythm device
- •Atrioventricular block (first degree (PR interval ≥ 220ms), second degree, or third degree) or left bundle branch block
- •Stroke or transient ischemic attack within the past 180 days
- •Life expectancy less than 12 months
- •Female known to be pregnant
- •Unable/unwilling to give informed consent
- •Unable/unwilling to comply with follow-up visits and study requirements
- •Less than 18 years of age
- •Active systemic infection
- •Cryoglobulinemia
- •Other conditions where the manipulation of the catheter would be unsafe (for example, intracardiac mural thrombus)
- •Participating in a concurrent clinical study that may confound the results of this study
- •Post-Electrophysiology Study Inclusion Criteria:
- •Subject must have one electrophysiology study documented inducible sustained (greater than or equal to 15 seconds) supraventricular tachycardia that is classified as AVNRT.
- •Post-Electrophysiology Study Exclusion Criteria:
- •Presence of a second inducible arrhythmia that could be confused with AVNRT during follow-up or will likely result in ablation within the next 6 months
- •Presence of inducible sustained ventricular tachycardia or fibrillation
- •Presence of an accessory pathway
- •Presence of abnormal conduction or refractoriness parameters of the atrioventricular conduction system.
- •Indication for a pacemaker, defibrillator or cardiac resynchronization therapy (CRT)
结局指标
主要结局
Chronic Safety (Through 6 Months) of the Freezor Xtra Catheter When Used for the Treatment of AVNRT Using an Endocardial Approach.
时间窗: 6 Months
Subjects who had at least one safety event during or after their cryoablation procedure or through 6 months of follow-up are considered a primary (chronic) safety failure. A safety event is defined as the occurrence of any adverse event that is adjudicated by the AE Adjudication Committee as being serious and study ablation procedure-related and/or Freezor Xtra Catheter related that: 1) Resulted in death, 2) Resulted in a life-threatening illness or injury, 3) Resulted in permanent impairment of a body function or permanent damage to a body structure, 4) Necessitated significant intervention, such as major surgery or even intravenous medical therapy (e.g., vasopressors), to prevent permanent impairment of a body function or permanent damage to a body structure, or 5) Required in-patient hospitalization or a prolongation of an existing hospital stay.
Chronic Effectiveness (Through 6 Months) of the Freezor Xtra Catheter for the Treatment of AVNRT Using an Endocardial Approach.
时间窗: 6 months
Subjects must have met both of the following acute and chronic conditions to be considered a chronic effectiveness (treatment) success: * Acute Success: The inability to induce more than one echo beat by the same pacing maneuvers that induced AVNRT before cryoablation (with drug provocation if required for induction before cryoablation) at the conclusion of the study cryoablation procedure assessment. * Chronic Success: Lack of documented recurrence of clinical AVNRT during the 6-month follow-up period after the study cryoablation procedure.
次要结局
- Chronic Effectiveness (Through 6 Months) of the Freezor Xtra Catheter for the Treatment of AVNRT in Subjects Who Achieved Acute Procedural Success.(6 Months)