SHERLOCK 3CG™ Diamond Tip Confirmation System (MODUS II)

A Single-Arm Prospective, Multi-Centered Study to Assess the SHERLOCK 3CG™ Diamond Tip Confirmation System

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 232

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Birtinya, Queensland, Australia, 4575
      • Sunshine Coast University Hospital
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Fiona Stanley Hospital
• United States
  • Nevada
    • Las Vegas, Nevada, United States, 89144
      • Summerlin Hospital and Medical Center
  • North Carolina
    • Greensboro, North Carolina, United States, 27401
      • Moses Cone Hospital
    • Greenville, North Carolina, United States, 27834
      • Vidant Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Washington
    • Spokane, Washington, United States, 99204
      • Providence Sacred Heart Medical Center
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • J.W. Ruby Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be adult males or females ≥ 21 years of age with identifiable alterations of cardiac rhythm. For this study, altered cardiac rhythm is defined as any condition that does not have a P-wave on ECG.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

PICC Placement with Study Device; PICC Placement with SHERLOCK 3CG™ Diamond TCS with MODUS II software

Procedure: PICC placement with SHERLOCK 3CG™ Diamond TCS with MODUS II software; The SHERLOCK 3CG™ Diamond Tip Confirmation System (TCS) is an FDA-cleared fully-integrated magnetic tracking and ECG-based PICC tip confirmation technology, indicated for use as an alternative to chest x-ray and fluoroscopy for PICC tip placement confirmation in adult patients without any alterations of cardiac rhythms that change the normal presentation of the P-wave. A software package, MODUS II, has been developed to accurately analyze the entire ECG complex and identify the correct placement of the PICC tip based on a patient's individual ECG, in the absence of an easily identifiable P-wave. This software system is designed to provide visual and/or audio cues to notify the PICC placer of the location of the PICC tip relative to the cavoatrial junction (CAJ) of the patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of successful PICC tip placement within the lower third of the superior vena cava (SVC) or in the cavoatrial junction (CAJ) using SLM2	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.	The PICC insertion procedure is 60-90 mins in duration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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	An independent, blinded radiologist will judge PICC tip position retrospectively against pre-specified anatomical criteria compared with findings of the SLM2.	The PICC insertion procedure is 60-90 mins in duration

Collaborators and Investigators

• Sponsor: C. R. Bard
• Investigators: Study Director: Rushil Sankpal, Becton Dickinson

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2018
• Primary Completion (Actual): June 15, 2021
• Study Completion (Actual): June 15, 2021

Study Registration Dates

• First Submitted: September 18, 2017
• First Submitted That Met QC Criteria: September 18, 2017
• First Posted (Actual): September 20, 2017

Study Record Updates

• Last Update Posted (Actual): October 20, 2021
• Last Update Submitted That Met QC Criteria: October 12, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Heart Block; Cardiac Complexes, Premature; Bundle-Branch Block; Premature Birth; Tachycardia; Atrial Flutter; Atrioventricular Block; Ventricular Premature Complexes; Atrial Premature Complexes
• Other Study ID Numbers: BAS-14-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No