Clinical trial NCT03288766: SHERLOCK 3CG™ Diamond Tip Confirmation System
Official title: A Single-Arm Prospective, Multi-Centered Study to Assess the SHERLOCK 3CG™ Diamond Tip Confirmation System
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Indication for Peripheral Intravenous Catheterization
Atrial Flutter
Premature Atrial Contraction
Premature Ventricular Contraction
Premature Junctional Contraction
Tachycardia
Atrioventricular Block
Bundle-Branch Block
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2017-09-20
Enrollment: 232
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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 position of peripherally inserted central catheters (PICCs) in adult subjects with altered cardiac rhythm.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of successful PICC tip placement within the lower third of the superior vena cava (SVC) or in the cavoatrial junction (CAJ) using SLM2
timeFrame: The PICC insertion procedure is 60-90 mins in duration
Secondary outcomes:
measure: 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
timeFrame: The PICC insertion procedure is 60-90 mins in duration
measure: Percent agreement between the site readings of the CXR (standard of care) versus those completed by an independent, blinded radiologist
timeFrame: The PICC insertion procedure is 60-90 mins in duration
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Summerlin Hospital and Medical Center
state: Nevada
city: Greensboro
country: United States
facility: Moses Cone Hospital
state: North Carolina
city: Greenville
country: United States
facility: Vidant Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Spokane
country: United States
facility: Providence Sacred Heart Medical Center
state: Washington
city: Morgantown
country: United States
facility: J.W. Ruby Memorial Hospital
state: West Virginia
city: Birtinya
country: Australia
facility: Sunshine Coast University Hospital
state: Queensland
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
Study officials:
affiliation: Becton Dickinson
name: Rushil Sankpal
role: STUDY_DIRECTOR
References: