NCT04658940已完成不适用
AcQBlate Force Sensing Ablation System US IDE for Atrial Flutter (AcQForce Flutter)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 47
- 主要终点
- Subjects Free From Procedure/Device Related Serious Adverse Events (SAEs)
研究概览
简要总结
The Acutus Medical AcQForce Flutter clinical study is a prospective, multi-center, non-randomized global study designed to demonstrate the safety and effectiveness of the AcQBlate Force Sensing Ablation System in the ablation management of symptomatic cavotricuspid isthmus dependent atrial flutter.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects are clinically indicated for de novo catheter ablation of typical atrial flutter.
- •At least one (1) documented episode of typical atrial flutter within 180 days (6 months) prior to enrollment, documented by 12-lead ECG.
- •Age 18 years or older at time of consent.
- •Subjects are willing and able to provide written informed consent to participate in the study and agree to comply with all follow-up visits and evaluations.
排除标准
- •In the opinion of the Investigator, any contraindication to the planned atrial ablation, including contraindications to anticoagulation therapy and any other significant uncontrolled or unstable medical condition (e.g. sepsis, acute metabolic illness, chronic kidney disease).
- •Inability to entrain CTI dependent AFL by standard pacing at procedure.
- •Any prior right atrial cavotricuspid isthmus ablation.
- •Any cardiac ablation for non-atrial flutter arrhythmias within 90 days prior to enrollment.
- •Any patient scheduled or anticipating an AF ablation within the follow-up period.
- •Use of amiodarone within 120 days prior to procedure.
- •Cardiac surgery within 60 days prior to enrollment.
- •ST-elevation myocardial infarction (STEMI) within 60 days prior to enrollment
- •Current unstable angina.
- •Documented atrial or ventricular tumors, clots, thrombus, within 30-days prior to enrollment.
- •Any history of a known hematologic disorder (bleeding/clotting).
- •Implantation of permanent leads of an implantable device in or through the right atrium within 90-days prior to enrollment.
- •Subjects with New York Heart Association (NYHA) Class IV heart failure within 6-months prior to enrollment.
- •Subjects with an ejection fraction less than 30% within 90 days of enrollment.
- •Percutaneous Transluminal Coronary Angioplasty (PTCA) within 30-days of enrollment.
- •Clinically significant structural heart disease (including moderate to severe tricuspid valve regurgitation, tricuspid valve stenosis, or tricuspid valve replacement; Ebstein's anomaly, or other congenital heart disease) that would preclude catheter introduction and placement, as determined by the Investigator.
- •Any cerebral ischemic/infarct event (excluding transient ischemic attacks) within 180 days prior to enrollment.
- •Body Mass Index (BMI) >42 kg/m
- •International Normalized Ratio (INR) >
- •Severe uncontrolled systemic hypertension (systolic pressure > 240 mm Hg) within the last 30-days.
- •Women who are pregnant or plan to become pregnant within the course of their participation in the investigation.
- •Current enrollment in any other study protocol where testing or results from the 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
Subjects Free From Procedure/Device Related Serious Adverse Events (SAEs)
时间窗: 7 days
Subjects free from a composite list of pre-specified procedure/device related Serious Adverse Events (SAEs)
Subjects Achieving Acute Procedural Success
时间窗: 20 minutes post ablation
Acute procedural success is defined as the demonstration of bidirectional cavotricuspid isthmus block at least 20 minutes following the last radiofrequency application at the cavotricuspid isthmus with the investigational System.
次要结局
未报告次要终点
研究者
研究点 (47)
Loading locations...
相似试验
撤回
不适用
AcQBlate Force Sensing Ablation System US IDE Study for Atrial FibrillationPersistent Atrial FibrillationParoxysmal Atrial FibrillationNCT04904354Acutus Medical
撤回
不适用
AcQBlate Force Confirmatory Study for Atrial ArrhythmiasAtrial ArrhythmiasNCT04429464Acutus Medical
终止
不适用
FIRM Ablation Versus Pulmonary Vein Isolation for the Treatment of Paroxysmal Atrial Fibrillation (PAF)Paroxysmal Atrial FibrillationNCT02703454Abbott Medical Devices51
撤回
不适用
Use of a Novel Contact Force Sensing Catheter for AF Ablation - Impact of TactiCath on Dormant Conduction Across the Pulmonary VeinsAtrial FibrillationNCT02666729Dhanunjaya Lakkireddy, MD, FACC
招募中
不适用
An Exploratory Study of Focal Pulse Ablation System in the Treatment of Atrial ArrhythmiaNCT06157437Hangzhou Dinova EP Technology Co., Ltd10