A Clinical Feasibility Study to Evaluate the Safety and Performance of Low-Energy Therapy in Patients With Atrial Fibrillation Energy Therapy in Patients With Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Translation
研究概览
简要总结
Assess the clinical safety and feasibility of MultiPulse Therapy (MPT) electrical stimulation waveform sequence in terminating paroxysmal and persistent atrial fibrillation.
详细描述
A prospective non-randomized feasibility study involving acute testing of MPT in subjects with paroxysmal and persistent AF during clinically indicated atrial fibrillation catheter ablation procedure.
Subjects will be split into 2 cohorts depending on status at time of procedure.
- In Atrial Fibrillation at time of procedure (Clinical AF)
- In Normal Sinus Rhythm at time of procedure
Subjects will be evaluated at the visits for the Clinically-Indicated Procedure per standard of care. A single follow-up at up to 30 days post-procedure is required to assess subjects for adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Male or female between 18 and 80 years of age
- •Willing and able to comply with the study protocol, provide a written informed consent
- •Currently indicated for atrial catheter ablation due to paroxysmal or early persistent atrial fibrillation
- •Current treatment and compliance with standard anticoagulation regimen, including uninterrupted OAC, with acceptable coagulation status, as determined by globally accepted risk stratification (CHA2DS2-VASc score) and the Principal Investigator
排除标准
- •Life expectancy of 1 year or less
- •AF due to reversible causes (e.g., hyperthyroidism, valve disease)
- •History of DC Cardioversion which failed to convert to AF to Normal Sinus Rhythm
- •Currently in AF for more than 3 months continuously
- •Chronic, long-standing persistent, or permanent atrial fibrillation
- •Allergy or contraindication to anticoagulation therapy
- •Presence of intracardiac thrombus (confirmed with TEE or ICE)
- •Existing Left Atrial Appendage closure device
- •Severely Dilated Left Atrium >5cm
- •NYHA Class IV heart failure at the time of enrollment
- •History of embolic stroke, Transient Ischemic Attack (TIA) or other thromboembolic event within the preceding 3 months.
- •Known hyper-coagulable state that increases risk of thrombus
- •History of myocardial infarction or coronary revascularization within the preceding 3 months.
- •History of sustained ventricular arrhythmia or cardiac arrest
- •Presence of chronically implanted lead in the CS
- •Presence of ventricular assist device, including intra-aortic balloon pump
- •Documented bradycardia (<40 BPM) at the time of the study
- •Morbid obesity: BMI>39 kg/m2
- •Presence of any prosthetic cardiac valve
- •History of significant tricuspid valvular disease requiring surgery
- •Moderate to severe mitral valve regurgitation (>40% regurgitation fraction)
- •Cognitive or mental health status that would interfere with study participation and proper informed consent
- •Cardiovascular anatomical defects that would complicate placement of the stimulation leads required by the protocol, including congenital heart disease and cardiac vein anomalies per the Investigator's discretion
- •Pregnancy confirmed by test within 7 days of procedure.
- •Inability to pass catheters to heart due to vascular limitations
- •Cardiovascular surgery or intervention within 1 month prior to enrollment or planned for up to 1 month after enrollment (other than the planned treatment procedure)
- •No active endocarditis
- •Any other medical condition which may affect the outcome of this study or safety of the subject as determined by the investigator
- •History of hemodynamic compromise due to valvular heart disease
- •Unstable CAD as determined by the investigator
- •Severe proximal three-vessel or left main coronary artery disease without revascularization as determined by the investigators
- •History of Hypertrophic Cardiomyopathy, Arrhythmogenic Right Ventricular Dysplasia, Congenital Heart Anomaly, Cardiac Amyloidosis or Cardiac Sarcoidosis
- •Any other condition which may affect the outcome of this study or safety of the subject as determined by the investigator
研究组 & 干预措施
Multi Pulse Therapy
Subjects will have AF induced and the Cardialen External Stimulation System (CESS) device will deliver electrical stimulation to terminate the arrhythmia.
干预措施: Multi Pulse Therapy (Device)
结局指标
主要结局
Translation
时间窗: Study procedure
Explore and enhance MPT parameters delivered in successful cases in a previous Cardialen AF study (CL001 / NCT02257112)
To define the safety of MPT for the treatment of atrial fibrillation in subjects
时间窗: Study procedure and 30 day post procedure
Adverse Events from procedure and 30 day follow up.
次要结局
未报告次要终点