Initial Safety and Performance of the CellFX® nsPFA™ Cardiac Surgery System for the Treatment of Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 9
- 主要终点
- Rate of acute major adverse events (MAEs)
研究概览
简要总结
This feasibility study will be conducted to demonstrate the initial safety and effectiveness of the CellFX® nsPFA™ Cardiac Clamp in performing a box lesion around the 4 pulmonary veins as an isolated procedure or as a part of a more extensive surgical ablation set in conjunction with concomitant cardiac surgical procedure.
详细描述
This study is a prospective, multicenter, single arm, non-randomized, feasibility study. Adult subjects who are clinically indicated for a concomitant cardiac surgical procedure will undergo left pulmonary vein, roof and floor ablations to form a left atrial posterior box. All subjects will return to the hospital between 60-120 days post-surgical ablation procedure to undergo a cardiac electrophysiology study with electroanatomical mapping to assess electrical isolation of the pulmonary veins and left atrial posterior wall
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be between 18 and 85 years of age
- •Subject is willing and capable of providing Informed Consent to undergo study procedures which includes surgical AF ablation and completing follow-up visits as specified in the clinical study protocol
- •Subject has history of documented atrial fibrillation within one year prior to enrollment. Documentation may include ECG, transtelephonic monitor (TTM), holter monitor or telemetry strip
- •Subject is scheduled to undergo non-emergent cardiac surgical procedure(s) to be performed on cardiopulmonary bypass including open-heart surgery for one or more of the following: Mitral valve repair or replacement, Aortic valve repair or replacement, Ascending aortic aneurysms, or Coronary artery bypass procedures
- •Left ventricular ejection fraction ≥ 30% (determined by echocardiography or cardiac catheterization performed within 60 days of enrollment as documented in patient medical history)
- •Subject has a life expectancy of at least 5 years
排除标准
- •Subject has an implantable electronic medical device. (i.e., pacemaker, ICD or CRT) or left atrial appendage device
- •Subject has a prosthetic heart valve
- •Stand-alone AF without indication(s) for concomitant Coronary Artery Bypass Graft (CABG) and/or valve surgery
- •Previous surgical Maze procedure
- •Prior cardiac surgery (Redo)
- •Wolff-Parkinson-White syndrome or other Supra-Ventricular arrhythmia, Atrioventricular (AV) nodal reentry
- •Subjects requiring surgery other than CABG and/or cardiac valve surgery and/or atrial septal defect repair.
- •Prior history of medical procedure involving instrumentation of the left atrium (e.g., previous ablation)
- •Class IV New York Heart Association (NYHA) heart failure symptoms
- •Prior history of cerebrovascular accident or TIA within 6 months or at any time if there is residual neurological deficit
- •Documented ST-segment elevation Myocardial Infarction (MI) within the 6 weeks prior to study enrollment
- •Need for emergent cardiac surgery (i.e., cardiogenic shock)
- •Known carotid artery stenosis greater than 80%
- •Current diagnosis of active systemic infection
- •Severe peripheral arterial occlusive disease defined as claudication with minimal exertion
- •Renal failure requiring dialysis or hepatic failure
- •A known drug and/or alcohol addiction
- •Mental impairment or other conditions which may not allow the subject to understand the nature, significance and scope of the study
- •Pregnancy or desire to get pregnant within 12-months of the study treatment
- •Preoperative need for an intra-aortic balloon pump or intravenous inotropes
- •Subjects who have been treated with thoracic radiation
- •Subjects in current chemotherapy
- •Subjects on long term treatment with oral or injected steroids (not including intermittent use of inhaled steroids for respiratory diseases)
- •Subjects with known hypertrophic obstructive cardiomyopathy
- •Subjects with known cold agglutinin
- •History of abnormal bleeding and/or clotting disorder
- •Contraindication to anticoagulation (i.e., Heparin, Dabigatran, Apixaban, Vitamin K Antagonists such as warfarin)
- •Solid organ or hematologic transplant, or currently being evaluated for an organ transplant
- •Body mass index > 40 kg/m2
- •Use of any other investigational drug, therapy, or device within 30 days prior to enrollment or concurrent participation in another research study
结局指标
主要结局
Rate of acute major adverse events (MAEs)
时间窗: Within 30 days post-ablation procedure
Acute major adverse events (MAEs) include, cardiac death, stroke, myocardial infarction, transient ischemic attack, or excessive bleeding.
Number of Participants with acute electrical isolation of the bilateral pulmonary veins and left atrial box
时间窗: Within 24 hours post-ablation procedure
The ablation procedure includes pulmonary vein isolation and a series of ablation lines to create a "box lesion" on the posterior left atrial free wall. At the conclusion of both the primary and concomitant procedures, exit and/or entrance block will be performed to confirm complete isolation of the pulmonary veins and the left atrial posterior wall.
次要结局
- Number of Participants with Long-Term Technical Success(60-120 days following the index procedure)
- Proportion of Participants with one or more SAEs(Up to 12-months post-procedure)