Remote Intracardiac Catheter Target Acquisition Using the Magnetecs Catheter Guidance Control and Imaging (CGCI) System
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Intracardiac anatomic site target acquisition and repetition acquisition success rates
研究概览
简要总结
The Magnetecs Catheter Guidance Control and Imaging (CGCI) system is a magnetic remote navigation system which is comprised of a magnetic chamber of eight electromagnets around the patient torso. The system can change the magnetic field almost instantaneously and enables almost real time manipulation of a special magnetic catheter (Maxwell mapping catheter) which results in accurate, repeatable, rapid and safe target acquisition within the four chambers of the human heart.
The trial is a prospective, non-randomized, clinical one designed to test the study hypotheses of (a) technical equivalence of the study device in comparison to other magnetic remote navigation systems, (b) performance equivalence or non-inferiority of the study device target acquisition capability compared to presently used catheter navigation techniques, and (c) safety equivalence or non-inferiority of the study device in comparison to catheter navigation devices using other navigation techniques.
详细描述
The CGCI system is comprised of (a) magnetic chamber of eight electromagnets around the patient torso, (b) the Maxwell ©, a 7Fr. Inquiry™ catheter with an attached magnetic pellet manufactured by St. Jude Medical, Inc. The Maxwell © is equivalent to a 7 Fr. Inquiry™ cleared under 510(K) K022380, and (c) a Agilis ES Active Sheath© which is a modified 7.5 Fr. Steerable Introducer is equivalent to the Agilis NxT™ Steerable Introducer, manufactured by St. Jude Medical, Inc. and cleared under 510(K) K061363.
Study Rationale: Current manual manipulations of mapping catheters are imprecise and difficult to control. The Magnetecs CGCI system enables almost real time manipulation of the Maxwell mapping catheter which results in accurate, repeatable, rapid and safe target acquisition. The CGCI System is intended to navigate a magnetic catheter within the four chambers of the human heart by orienting and moving the catheter tip to designated anatomically significant targets.
Design: A prospective, non-randomized, clinical trial designed to test the study hypotheses of (a) technical equivalence of the study device in comparison to other magnetic remote navigation systems, (b) performance equivalence or non-inferiority of the study device target acquisition capability compared to presently used catheter navigation techniques, and (c) safety equivalence or non-inferiority of the study device in comparison to catheter navigation devices using other navigation techniques.
Target Population:Patients who have recurrent cardiac rhythm disturbances and who meet clinically recognized indications for performance of an intracardiac mapping procedure.
Planned Number of Subjects: A total of 40 patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Patients who are clinically eligible for catheter based therapy of cardiac arrhythmias
- •Body Mass Index (BMI) < 40
- •Signed Informed Consent
排除标准
- •Indication for atrial fibrillation ablation
- •Indication for ischemic ventricular tachycardia ablation
- •Severe cerebrovascular disease
- •Serum creatinine >2.5
- •Active gastrointestinal bleeding
- •Active infection or fever
- •Short life expectancy (<6 months)
- •Severe uncontrolled systemic hypertension
- •Severe electrolyte imbalance
- •Congestive heart failure (NYHA Class IV)
- •Unstable angina
- •Recent MI (<4 weeks)
- •Bleeding or clotting disorders
- •Uncontrolled diabetes
- •Inability to receive IV Anticoagulants
- •Presence of intracardiac thrombus
- •Patients with prosthetic cardiac valves
- •Patients with permanent pacemakers or ICD's
- •Enrollment in any other ongoing clinical trial
结局指标
主要结局
Intracardiac anatomic site target acquisition and repetition acquisition success rates
时间窗: within 1 minute
Intracardiac anatomic site target acquisition and repetition acquisition success rates of a mapping catheter remotely navigated by the Magnetecs CGCI system
Serious adverse event rate
时间窗: within 7 days
Serious adverse event rate at intracardiac anatomic site target acquisition of a mapping catheter remotely navigated by the Magnetecs CGCI system
次要结局
- Intracardiac anatomic site target acquisition and repetition acquisition duration(within 1 minute)
- Pacing stimulation thresholds levels at the target intracardiac anatomic sites remotely and manually acquired(within 10 minutes)
- Electrogram frequency spectrum and signal/noise levels at the target intracardiac anatomic sites remotely and manually acquired by the Magnetecs CGCI system and a conventional catheter manually operated respectively.(within 1 minute)