SHERLOCK 3CG™ Diamond Tip Confirmation System



Status:Recruiting
Conditions:Atrial Fibrillation, Cardiology, Cardiology, Women's Studies
Therapuetic Areas:Cardiology / Vascular Diseases, Reproductive
Healthy:No
Age Range:21 - Any
Updated:2/9/2019
Start Date:April 19, 2018
End Date:February 28, 2021
Contact:Rushil Sankpal
Email:Rushil.Sankpal@bd.com
Phone:908-370-8263

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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.

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.

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 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 device-related infection, 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.
We found this trial at
7
sites
Greenville, North Carolina 27834
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Phone: 216-444-5229
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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Celebration, Florida 34747
Phone: 407-303-4235
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Celebration, FL
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Greensboro, North Carolina 27401
Phone: 336-832-3702
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Greensboro, NC
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Las Vegas, Nevada 89144
Phone: 702-419-5201
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Las Vegas, NV
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Morgantown, West Virginia 26505
Phone: 304-598-4000
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Morgantown, WV
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Spokane, Washington 99204
Phone: 509-474-3821
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Spokane, WA
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