NCT04904354撤回不适用
AcQBlate Force Sensing Ablation System US IDE Study for Atrial Fibrillation (AcQForce AF)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Proportion of subjects demonstrating freedom from AF/AT/AFL following a blanking period
研究概览
简要总结
The AcQForce AF clinical study is a prospective, multi-center, non-randomized global clinical study.
详细描述
The AcQForce AF clinical study is a prospective, multi-center, non-randomized global clinical study designed to demonstrate the safety and efficacy of the AcQBlate Force Sensing System in the ablation treatment of symptomatic, drug-refractory atrial fibrillation in two subject cohorts: paroxysmal atrial fibrillation, and persistent atrial fibrillation. Data will be used to support pre-market approval applications (PMAs).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Male or female between the ages of 18 to 80 years at time of consent
- •Clinically indicated and scheduled for a de novo catheter ablation of symptomatic PAF or PerAF.
- •Refractory to Antiarrhythmic Drug (AAD) treatment
- •Willing and able to provide written informed consent to participate in the study and agree to comply with all follow-up visits and evaluations for the duration of the study.
排除标准
- •In the opinion of the investigator, any contraindication to the planned atrial ablation, including anticoagulation contraindications or sepsis.
- •Continuous episodes of AF Duration:
- •PAF: AF duration lasting longer than 7 days
- •Persistent AF: AF duration lasting longer than 12-months.
- •Atrial arrhythmias secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause.
- •An implantable cardiac defibrillator (ICD) or pacemaker.
- •Previous history of left atrial ablation (including surgical treatment) for AF/AT/AFL.
- •Structural heart disease or cardiac history as described below:
- •Left ventricular ejection fraction (LVEF) < 40% based on transthoracic echocardiogram (TTE) within the previous 180-days.
- •Left atrial size > 55 mm based on transthoracic echocardiogram (TTE) measurement of the anteroposterior diameter, parasternal long-axis view in M Mode and performed within the previous 180-days.
- •Evidence of heart failure (NYHA Class III or IV)
- •Previous cardiac surgery, ventriculotomy, or atriotomy (excluding atriotomy for coronary artery bypass).
- •Previous cardiac valvular surgical or percutaneous procedure, or prosthetic valve.
- •Coronary artery bypass graft (CABG) within the last 180-days or coronary angioplasty (PTCA) procedure within the last 90-days.
- •Unstable angina or ongoing myocardial ischemia.
- •Myocardial infarction within the previous 180-days (sub-endocardial infarct within previous 90-days).
- •Severe uncontrolled systemic hypertension (systolic pressure > 240 mm Hg, diastolic pressure > 140 mm Hg) recorded within the last 30 days.
- •Moderate or severe valvular heart disease (stenosis or regurgitation).
- •Interatrial baffle, closure device, patch, or patent foramen ovale (PFO) occluder.
- •Presence of a left atrial appendage occlusion device.
- •Previous PV stenting or evidence of PV stenosis.
- •Presence of Left Atrial Thrombus
- •Body Mass Index (BMI) > 42 kg/m2
- •Estimated Glomerular Filtration Rate (eGFR) of <40 mL/min/1.73 m2 (by Modification of Diet in Renal Disease formula)
- •History of blood clotting or bleeding disease.
- •ANY prior history of documented cerebral infarct, or systemic embolism (excluding post-operative deep vein thrombosis (DVT)).
- •History of chronic obstructive pulmonary disease (COPD) requiring oral or IV steroid use in the previous 12-months.
- •History of obstructive sleep apnea not currently being treated.
- •Pregnant or lactating (current or anticipated during study follow-up).
- •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.
- •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).
结局指标
主要结局
Proportion of subjects demonstrating freedom from AF/AT/AFL following a blanking period
时间窗: 12 months
Freedom from recurrence of atrial arrhythmias
Subjects who are free from device and/or procedure related Major Adverse Events (MAEs)
时间窗: 12 months
Subjects free from a composite list of pre-specified procedure/device related Major Adverse Events (MAEs)
次要结局
- Recording of all serious adverse events/device effects(12 months)
研究者
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