SHERLOCK 3CG™ Diamond Tip Confirmation System (MODUS II)

C. R. Bard

Status: Terminated

Conditions: Premature Junctional Contraction; Atrioventricular Block; Atrial Flutter; Tachycardia; Bundle-Branch Block; Premature Atrial Contraction; Premature Ventricular Contraction; Indication for Peripheral Intravenous Catheterization

Treatments: Procedure: PICC placement with SHERLOCK 3CG™ Diamond TCS with MODUS II software

Study type: Observational

Funder types: Industry

Identifiers

NCT03288766

BAS-14-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 232 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

232 participants in 1 patient group

PICC Placement with Study Device

Description:

PICC Placement with SHERLOCK 3CG™ Diamond TCS with MODUS II software

Treatment:

Procedure: PICC placement with SHERLOCK 3CG™ Diamond TCS with MODUS II software