Status:
TERMINATED
SHERLOCK 3CG™ Diamond Tip Confirmation System
Lead Sponsor:
C. R. Bard
Conditions:
Indication for Peripheral Intravenous Catheterization
Atrial Flutter
Eligibility:
All Genders
21+ years
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 ...
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 subje...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 19 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 15 2021
Estimated Enrollment :
232 Patients enrolled
Trial Details
Trial ID
NCT03288766
Start Date
April 19 2018
End Date
June 15 2021
Last Update
October 20 2021
Active Locations (8)
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1
Summerlin Hospital and Medical Center
Las Vegas, Nevada, United States, 89144
2
Moses Cone Hospital
Greensboro, North Carolina, United States, 27401
3
Vidant Medical Center
Greenville, North Carolina, United States, 27834
4
Cleveland Clinic
Cleveland, Ohio, United States, 44195