iCLAS™ for Persistent Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 215
- 试验地点
- 32
- 主要终点
- Analysis of the proportion of subjects who are free from device/procedure related Major Adverse Events (MAEs) that occur following the cryoablation procedure.
研究概览
简要总结
Clinical study to evaluate the safety and efficacy of the Adagio AF Cryoablation System (iCLAS™) in the ablation treatment of symptomatic, persistent atrial fibrillation (PsAF). Data will be used to support a pre-market application (PMA)
详细描述
A staged pre-market, single-arm, clinical study designed to collect acute and long-term safety and efficacy data for the Adagio AF Cryoablation System (iCLAS™). Patient population will consist of symptomatic, persistent AF subjects completing a de novo ablation procedure. Enrollment will be 200 subjects at up to 20 global investigational sites. Subjects will receive an ablation with the ultra-low cryoablation device. Follow-up will include assessment at one, three, six, and twelve months.
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
- •IC1 Male or female between the ages of 18 and 80 years
- •IC2 Currently scheduled for an ablation of symptomatic, PsAF defined as continuous AF that is sustained > 7-days and ≤ 12 months and documented by the following: a. Physician's note indicating continuous AF > 7 days and ≤ 12 months, AND b. One of the following: i. 24-hour Holter within 180 days of enrollment showing continuous AF, OR ii. Two electrocardiograms from any forms of rhythm monitoring (e.g., 12-lead ECGs or single lead ECGs) completed ≥ 7 days apart within 180 days of enrollment.
- •IC3 Refractory to at least one class I or III AAD. (Refractory defined as not effective, not tolerated or not desired)
- •IC4 Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study
- •IC5 Willingness and ability to give an informed consent
排除标准
- •EC 1 In the opinion of the Investigator, any known contraindication to an atrial ablation, TEE, or anticoagulation. Including, but not limited to, the identification of any atrial thrombus or evidence of sepsis
- •EC 2 Any duration of continuous AF lasting longer than 12-months
- •EC 3 History of previous left atrial ablation or surgical treatment for AF/AFL/AT
- •EC 4 Atrial fibrillation secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause
- •EC 5 Structural heart disease as described below:
- •Left ventricular ejection fraction (LVEF) < 40% based on most recent TTE
- •Left atrial size > 55 mm (parasternal long axis view) documented within 6-months of screening
- •NYHA Class III or IV heart failure documented within the previous 12-months
- •An implanted pacemaker or ICD
- •Previous cardiac surgery, ventriculotomy, or atriotomy (excluding atriotomy for CABG),
- •Previous cardiac valvular surgical or percutaneous procedure, or prosthetic valve
- •Interatrial baffle, closure device, patch, or PFO occluder
- •Presence of a left atrial appendage occlusion device
- •Presence of any pulmonary vein stenting devices
- •Coronary artery bypass graft (CABG) or PTCA procedure within 6 months prior to procedure
- •Unstable angina or ongoing myocardial ischemia
- •Myocardial infarction within the previous six (6) months prior to procedure
- •Moderate or severe mitral insufficiency or stenosis based on most recent TTE
- •Atrial myxoma
- •Significant congential anomaly
- •EC 6 BMI > 40
- •BMI >35 and no prior sponsor approval into the study
- •EC 7 Any previous history of cryoglobulinemia
- •EC 8 History of blood clotting or bleeding disease
- •EC 9 History of severe COPD requiring steroid use in the previous 12-months
- •EC 10 History of severe sleep apnea (AHI > 30) not currently treated with a CPAP machine or other mechanical device
- •EC 11 Any prior history of documented cerebral infarct including recent TIA (within one year) or systemic embolism (excluding a post-operative DVT)
- •EC 12 Any prior history or current evidence of hemidiaphragmatic paralysis
- •EC 13 Pregnant or lactating (current or anticipated during study follow-up)
- •EC 14 Current enrollment in any other study protocol where testing or results from that study may interfere with the procedure or outcome measurements for this study
- •EC 15 Any other condition that, in the judgment of the investigator, makes the patient a poor candidate for this procedure, the study or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, terminal illness with a life expectancy of less than two years, extensive travel away from the research center, COVID-19 related concerns)
研究组 & 干预措施
iCLAS Ablation
Ablation of the left and right atrium with the Adagio Medical iCLAS System
干预措施: Adagio AF Cryoablation System (iCLAS™) (Device)
结局指标
主要结局
Analysis of the proportion of subjects who are free from device/procedure related Major Adverse Events (MAEs) that occur following the cryoablation procedure.
时间窗: 12-months
MAEs include any of the following: * Death * Myocardial infarction * Cardiac perforation/pericardial tamponade * Cerebral infarct or systemic embolism * Major bleeding requiring transfusion of blood products * Mitral or tricuspid valve damage * Symptomatic pulmonary vein stenosis * Severe (≥ 70%) pulmonary vein stenosis * Permanent phrenic nerve injury * Access site complications requiring pharmacological or surgical intervention * Atrio-esophageal fistula * Pericarditis * Heart block requiring a permanent pacemaker * Vagal nerve injury with GI dysmotility * Other serious adverse device effects (SADEs), including TIAs, adjudicated by an independent Clinical Events Committee (CEC) as "probably or definitely related" to the Adagio System
Analysis of the proportion of subjects receiving a single cryoablation who are free from any documented left atrial arrhythmia (AF/AFL/AT).
时间窗: 12-months
The primary effectiveness endpoint will be based on a centralized core lab interpretation of the recordings used in the endpoint analysis.
Analysis of the Proportion of Subjects Who Are Free From Device/Procedure Related Major Adverse Events (MAEs) That Occur Following the Cryoablation Procedure
时间窗: 12-months
Analysis of the proportion of subjects who are free from device/procedure related Major Adverse Events (MAEs) that occur following the cryoablation procedure. MAEs include any of the following: * Death * Myocardial infarction * Cardiac perforation/pericardial tamponade * Cerebral infarct or systemic embolism * Major bleeding requiring transfusion of blood products * Mitral or tricuspid valve damage * Symptomatic pulmonary vein stenosis * Severe (≥ 70%) pulmonary vein stenosis * Permanent phrenic nerve injury * Access site complications requiring pharmacological or surgical intervention * Atrio-esophageal fistula * Pericarditis * Heart block requiring a permanent pacemaker * Vagal nerve injury with GI dysmotility * Other serious adverse device effects (SADEs), including TIAs, adjudicated by an independent Clinical Events Committee (CEC) as "probably or definitely related" to the Adagio System
Analysis of the Proportion of Subjects Receiving a Single Cryoablation Who Are Free From Any Documented Left Atrial Arrhythmia (AF/AFL/AT) Following the Blanking Period Lasting Longer Than 30 Seconds on a Continuous 24-hour ECG Recording (Holter Monitor).
时间窗: 12-months
Analysis of the proportion of subjects receiving a single cryoablation who are free from any documented left atrial arrhythmia (AF/AFL/AT) following the Blanking Period lasting longer than 30 seconds on a continuous 24-hour ECG recording (Holter monitor). The primary effectiveness endpoint will be based on a centralized core lab interpretation of the recordings used in the endpoint analysis.
次要结局
- Recording and analysis of all identified SAEs and SADEs through 12-months post-procedure.(12-months)
- Analysis of the proportion of subjects with acute procedural (ablation) success(20-minutes following last ablation)
- Analysis of the Proportion of Subjects With Acute Procedural (Ablation) Success(20-minutes following last ablation)