Ablation for the Treatment of Concomitant Atrial Fibrillation in Non-Paroxysmal Patients (ATTAC-AF)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 13
- 主要终点
- Primary Safety Endpoint
研究概览
简要总结
The purpose of this study is to demonstrate that the Estech COBRA Surgical System is an effective treatment for patients with irregular heart beats who are undergoing heart surgery.
详细描述
The objective of the trial is to demonstrate that the creation of epicardial and endocardial lesions with temperature-controlled radiofrequency (TCRF) ablation applied using the Estech COBRA® Surgical System during concomitant heart surgery is a safe and effective treatment for non-paroxysmal atrial fibrillation (AF).
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
- •All subjects are required to meet the following inclusion criteria in order to be considered eligible for participation in this trial:
- •Subject is scheduled to undergo elective on-pump cardiac surgical procedure(s) for one or more of the following:
- •Mitral valve repair or replacement,
- •Aortic valve repair or replacement,
- •Tricuspid valve repair or replacement, or
- •Coronary Artery Bypass procedures;
- •Subject has history of a non-paroxysmal form of AF for greater than 3 months and has failed at least one attempt at electrical cardioversion or had a successful attempt at electrical cardioversion but had a recurrence of AF within 30 days of the cardioversion;
- •Age 18 to 80 years old;
- •Left ventricular ejection fraction (LVEF) ≥ 30%;
- •Subject has no contraindications to intraoperative transesophageal echocardiography;
- •Subject has a life expectancy greater than 12 months; and
- •Willing and capable of providing Informed Consent to undergo surgery and participate in all examinations and follow-ups associated with this clinical trial.
- •A subject is considered to have failed electrical cardioversion if they did not achieve sinus rhythm for at least 30 seconds following the attempted cardioversion.
排除标准
- •Subjects will be excluded from participating in this trial if they meet any of the following exclusion criteria:
- •History of non-paroxysmal AF less than 3 months or for more than 5 years;
- •History of prior cardiac ablative surgical or catheter-based therapy;
- •Previous cardiac surgery (redo) or other intrapericardial procedures;
- •Class IV NYHA heart failure;
- •Known carotid artery stenosis greater than 80% or previous carotid endarterectomy;
- •Wolff-Parkinson-White syndrome;
- •Need for emergent cardiac surgery (e.g., cardiogenic shock);
- •Untreated hyperthyroidism;
- •Untreated hypothyroidism;
- •Acute pulmonary disease;
- •Electrolyte imbalance;
- •History of myocarditis;
- •Presence of a previously implanted device in or adjacent to the treatment target area that may alter the delivery of therapy (e.g., valvular prosthesis or ring, pacemaker with leads in coronary sinus or internal defibrillator leads);
- •History of pericarditis;
- •Previous left phrenic nerve paralysis;
- •Bullous lung disease;
- •Presence of active endocarditis, or local or systemic infection;
- •Recent myocardial infarction (< 3 months);
- •Renal failure requiring dialysis or hepatic failure or creatinine of >2 mg/dL preoperatively;
- •Antiarrhythmic drug therapy required for the treatment of a ventricular arrhythmia;
- •Preoperative need for an intra-aortic balloon pump or intravenous inotropes;
- •Severe peripheral arterial occlusive disease defined as claudication with minimal exertion;
- •Therapy resulting in compromised tissue integrity including: thoracic radiation, chemotherapy, long term treatment with oral or injected steroids, or known connective tissue disorders;
- •Documented left atrial size of 6 cm or more;
- •History of cerebrovascular disease or accident, including stroke or transient ischemic attack (TIA) within 6 months prior to enrollment;
- •Known contraindication to anticoagulant therapy or inability to comply with anticoagulant therapy;
- •Pregnancy, planned pregnancy (females of childbearing potential must have a negative pregnancy test prior to enrollment and agree not to become pregnant during the trial) or breastfeeding;
- •Forced expiratory volume in 1 second less than 30% of predicted value or need for home oxygen therapy; or
- •Surgical management of hypertrophic obstructive cardiomyopathy.
研究组 & 干预措施
The Estech COBRA® Surgical System
干预措施: The Estech COBRA® Surgical System (Device)
结局指标
主要结局
Primary Safety Endpoint
时间窗: The primary safety endpoint will be assessed within 30 days of the procedure or hospital discharge, whichever is later.
A composite safety endpoint consisting of the proportion of subjects that experience one or more of the following early onset (i.e., within 30 days of the TCRF ablation procedure or hospital discharge, whichever is later) serious adverse events (SAEs): * Cardiac death; * Stroke and transient ischemic attack (TIA); * Myocardial infarction (MI); * Excessive bleeding; or * Atrioesophageal fistula.
Primary Efficacy Endpoint
时间窗: The primary efficacy endpoint will be assessed following the blanking interval through Month 12.
Proportion of subjects that achieve procedural and therapeutic success. Procedural success is defined as the performance of the protocol specified lesions with the designated devices. Therapeutic success is defined as freedom from AF, AFL (atrial flutter) and AT (atrial tachycardia, not including sinus tachycardia) following the blanking interval through Month 12.
次要结局
- Secondary Efficacy Endpoint(The secondary efficacy endpoints will be assessed following the procedure through the 12 month follow-up visit.)
- Secondary Safety Endpoint(The secondary safety endpoints will be assessed up to 3 years post procedure.)