A Single-Arm Prospective, Multi-Centered Study to Assess the SHERLOCK 3CG™ Diamond Tip Confirmation System
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 232
- 试验地点
- 8
- 主要终点
- Rate of successful PICC tip placement within the lower third of the superior vena cava (SVC) or in the cavoatrial junction (CAJ) using SLM2
研究概览
简要总结
This study is a single-arm, prospective, multi-center study to assess clinical performance of the SHERLOCK 3CG™ Diamond Tip Confirmation System (TCS) with MODUS II software for confirming correct tip position of peripherally inserted central catheters (PICCs) in adult subjects with altered cardiac rhythm.
详细描述
This study is intended to confirm the accuracy of the SHERLOCK 3CG™ Diamond TCS with the addition of MODUS II (SLM2) software to eliminate the need for post-procedural chest x-ray (CXR) in adult subjects with cardiac abnormalities that alter presentation of the P-wave. Atrial fibrillation will be the primary target while data on pacemaker driven rhythms and other arrhythmia types will also be collected to explore overall performance.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, ≥ 21 years of age with altered cardiac rhythm (no recognizable P-wave on standard ECG) with diagnosis of specific arrhythmia type or identification of pacemaker driven rhythms as defined below:
- •Atrial fibrillation with history of diagnosis per 12-lead ECG in medical record or diagnosed via bedside telemetry by study team RN at assessment, or
- •All other arrhythmias (including but not limited to atrial flutter, PAC, PVC, PJC, tachycardia, AV Block, BB Block) with history of diagnosis per 12-lead ECG in medical record or diagnosed via bedside telemetry by cardiac unit RN at assessment, or retrospectively by site cardiologist, or
- •Pacemaker driven rhythm with temporary or permanent pacemaker device in place;
- •Subject requires PICC placement as part of standard of care;
- •Subject or Legally Authorized Representative (LAR) has signed an Informed Consent Form (ICF).
排除标准
- •Subject has a contraindication to PICC placement as listed in the Instructions for Use (IFU) to include:
- •The presence of bacteremia or septicemia (known or suspected),
- •The patient's body size is insufficient to accommodate the size of the implanted device,
- •The patient is known or is suspected to be allergic to materials contained in the device,
- •Past irradiation of prospective insertion site,
- •Previous episodes of venous thrombosis or vascular surgical procedures at the prospective placement site,
- •Local tissue factors will prevent proper device stabilization and/or access;
- •Subjects who previously had a PICC in place and require a PICC exchange;
- •Subject has presence of active resting tremor (i.e. Parkinson's, Multiple Sclerosis, etc.) deemed by Investigator to have potential impact on procedure accuracy;
- •Subjects who are pregnant or think they may be pregnant.
结局指标
主要结局
Rate of successful PICC tip placement within the lower third of the superior vena cava (SVC) or in the cavoatrial junction (CAJ) using SLM2
时间窗: The PICC insertion procedure is 60-90 mins in duration
Tip positioning is determined at bedside by the software via the Green Diamond Indicator (GDI+) and confirmed by CXR. PICC tip placement will be considered successful if it is determined to be in the lower 1/3 of the SVC or in the CAJ by an independent, blinded radiologist judging position retrospectively against pre-specified anatomical criteria.
次要结局
- Rate of successful PICC tip placement within the lower third of the superior vena cava (SVC) or in the cavoatrial junction (CAJ) using SLM2 in the absence of a GDI(The PICC insertion procedure is 60-90 mins in duration)
- Percent agreement between the site readings of the CXR (standard of care) versus those completed by an independent, blinded radiologist(The PICC insertion procedure is 60-90 mins in duration)