SHERLOCK 3CG™ Diamond Tip Confirmation System

Terminated

• Conditions: Bundle-Branch Block; Atrial Flutter; Atrioventricular Block; Premature Atrial Contraction; Indication for Peripheral Intravenous Catheterization; Premature Ventricular Contraction; Premature Junctional Contraction; Tachycardia
• Interventions: Procedure: PICC placement with SHERLOCK 3CG™ Diamond TCS with MODUS II software

• Registration Number: NCT03288766
• Lead Sponsor: C. R. Bard

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-09-18
• Study First Submitted QC: 2017-09-18
• Study First Posted: 2017-09-20
• Study Start: 2018-04-19
• Status Verified: 2021-01
• Primary Completion: 2021-06-15
• Study Completion: 2021-06-15
• Last Update Submitted: 2021-10-12
• Last Update Posted: 2021-10-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 232

Inclusion Criteria

• 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:

  1. 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
  2. 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
  3. 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).

Exclusion Criteria

• Subject has a contraindication to PICC placement as listed in the Instructions for Use (IFU) to include:

  1. The presence of bacteremia or septicemia (known or suspected),
  2. The patient's body size is insufficient to accommodate the size of the implanted device,
  3. The patient is known or is suspected to be allergic to materials contained in the device,
  4. Past irradiation of prospective insertion site,
  5. Previous episodes of venous thrombosis or vascular surgical procedures at the prospective placement site,
  6. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PICC Placement with Study Device	PICC placement with SHERLOCK 3CG™ Diamond TCS with MODUS II software	PICC Placement with SHERLOCK 3CG™ Diamond TCS with MODUS II software

Primary Outcome Measures

Name	Time	Method
Rate of successful PICC tip placement within the lower third of the superior vena cava (SVC) or in the cavoatrial junction (CAJ) using SLM2	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.

Secondary Outcome Measures

Name	Time	Method
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	It is expected there will be some cases where the MODUS II software may fail to present a Green Diamond Indicator (GDI-). In the absence of a GDI, tip positioning is determined at bedside using magnetic tracking and external measurement per hospital protocol, with CXR required for tip confirmation. 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.
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	An independent, blinded radiologist will judge PICC tip position retrospectively against pre-specified anatomical criteria compared with findings of the SLM2.

Trial Locations

Locations (8)

Summerlin Hospital and Medical Center; 🇺🇸 Las Vegas, Nevada, United States

Vidant Medical Center; 🇺🇸 Greenville, North Carolina, United States

Moses Cone Hospital; 🇺🇸 Greensboro, North Carolina, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

J.W. Ruby Memorial Hospital; 🇺🇸 Morgantown, West Virginia, United States

Sunshine Coast University Hospital; 🇦🇺 Birtinya, Queensland, Australia

Providence Sacred Heart Medical Center; 🇺🇸 Spokane, Washington, United States

Fiona Stanley Hospital; 🇦🇺 Murdoch, Western Australia, Australia