SHERLOCK 3CG Diamond Tip Confirmation System

  • STATUS
    Recruiting
  • End date
    Mar 28, 2022
  • participants needed
    605
  • sponsor
    C. R. Bard
Updated on 29 January 2021
Investigator
Rushil Sankpal
Primary Contact
John Hunter Hospital (0.3 mi away) Contact
+10 other location
electrocardiogram
atrial fibrillation
arrhythmia
fibrillation
ventricular extrasystoles
atrial flutter
12 lead ECG
av block

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.

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.

Details
Condition Right bundle branch block, Arrhythmia, Atrioventricular Block, Atrial Flutter, Premature ventricular contractions, Tachycardia, Atrial Premature Complex, Fast Heart Rate (Tachycardia), Indication for Peripheral Intravenous Catheterization, Premature Junctional Contraction, Dysrhythmia, av block, block, av, ventricular extrasystoles, pacs, apcs, premature atrial complex, bundle branch block
Treatment PICC placement with SHERLOCK 3CG™ Diamond TCS with MODUS II software
Clinical Study IdentifierNCT03288766
SponsorC. R. Bard
Last Modified on29 January 2021

Eligibility

Yes No Not Sure

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
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)

Exclusion Criteria

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
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