SHERLOCK 3CG™ Diamond Tip Confirmation System

Last updated: October 12, 2021
Sponsor: C. R. Bard
Overall Status: Terminated

Phase

N/A

Condition

Fast Heart Rate (Tachycardia)

Heart Defect

Arrhythmia

Treatment

N/A

Clinical Study ID

NCT03288766
BAS-14-003
  • Ages > 21
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female, ≥ 21 years of age with altered cardiac rhythm (no recognizable P-waveon standard ECG) with diagnosis of specific arrhythmia type or identification ofpacemaker driven rhythms as defined below:
  1. Atrial fibrillation with history of diagnosis per 12-lead ECG in medical recordor 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 ECGin medical record or diagnosed via bedside telemetry by cardiac unit RN atassessment, 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

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 implanteddevice,
  3. The patient is known or is suspected to be allergic to materials contained in thedevice,
  4. Past irradiation of prospective insertion site,
  5. Previous episodes of venous thrombosis or vascular surgical procedures at theprospective 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

Total Participants: 232
Study Start date:
April 19, 2018
Estimated Completion Date:
June 15, 2021

Study 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.

Connect with a study center

  • St. George Hospital

    Kogarah, New South Wales 2217
    Australia

    Site Not Available

  • John Hunter Hospital

    Newcastle, New South Wales 2305
    Australia

    Site Not Available

  • Sunshine Coast University Hospital

    Birtinya, Queensland 4575
    Australia

    Site Not Available

  • Fiona Stanley Hospital

    Murdoch, Western Australia 6150
    Australia

    Site Not Available

  • Advent Health Celebration Hospital

    Celebration, Florida 34747
    United States

    Site Not Available

  • Summerlin Hospital and Medical Center

    Las Vegas, Nevada 89144
    United States

    Site Not Available

  • Moses Cone Hospital

    Greensboro, North Carolina 27401
    United States

    Site Not Available

  • Vidant Medical Center

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Providence Sacred Heart Medical Center

    Spokane, Washington 99204
    United States

    Site Not Available

  • J.W. Ruby Memorial Hospital

    Morgantown, West Virginia 26505
    United States

    Site Not Available

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