NCT04206917终止不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 9
- 主要终点
- To define the safety of MPT for the treatment of atrial fibrillation in subjects
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
结局指标
主要结局
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.
Translation
时间窗: Study procedure
Explore and enhance MPT parameters delivered in successful cases in a previous Cardialen AF study (CL001 / NCT02257112)
次要结局
未报告次要终点
研究者
研究点 (9)
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