HeRO Vascular Access Device Bacteremia Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00889564
Recruitment Status : Completed
First Posted : April 29, 2009
Last Update Posted : August 8, 2017
Integra Clinical Trial Solutions - statistical analysis
Ross, John, M.D.
Information provided by (Responsible Party):
Merit Medical Systems, Inc.

Brief Summary:
The purpose of this study is to compare the safety and effectiveness of the HeRO Vascular Access Device in access challenged (e.g., catheter-dependent) hemodialysis patients. It is hypothesized the bacteremia rate associated with the HeRO device will be lower than a historical literature control of tunneled dialysis catheters.

Condition or disease Intervention/treatment Phase
Hemodialysis Device: HeRO Vascular Access Device Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: HeRO Vascular Access Device Bacteremia Study
Study Start Date : March 2006
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
U.S. FDA Resources

Intervention Details:
    Device: HeRO Vascular Access Device
    Long-term subcutaneous vascular access device for hemodialysis

Primary Outcome Measures :
  1. HeRO superiority in device and implant procedure-related bacteremia compared to historical tunneled dialysis catheter literature control [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Incidence of serious device or implant procedure-related serious adverse events and loss of secondary patency [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 21 years of age or older.
  2. Male or non-pregnant female.
  3. Life expectancy less than 1 year.
  4. ESRD on hemodialysis with poor remaining venous access sites for creation of an AV fistula or placement of a graft in the upper extremities.
  5. Implant side central venous system that surgeon believes can be accessed with interventional devices and can accommodate the 19 Fr GVAS device.
  6. Potential GVAS target brachial artery ≥ 3 mm in diameter determined by any suitable measure.
  7. Ability to understand and provide written informed consent.
  8. Willing and able to cooperate with follow-up examinations.

Exclusion Criteria:

  1. Documented history of drug abuse within six months prior to enrollment.
  2. "Planned" concomitant surgical procedure or previous major surgery within 30 days, excluding vascular access related procedures.
  3. Currently being treated with another investigational device or drug.
  4. Known bleeding diathesis or hypercoaguable state.
  5. Peripheral white blood cell count 1.5 K/mm3 or platelet count 50 K/mm3.
  6. Degenerative connective tissue disease, e.g., Marfan's and Ehlers Danlos Syndrome. Subjects with Lupus Erythematosus may be enrolled if receiving no immunosuppressants or low dose prednisone only (< 10 mg/day orally).
  7. Subjects with known or suspected concomitant active bacterial, fungal, viral, or parasitic infection. Subjects with Hepatitis B and/or Hepatitis C may be enrolled. Subjects who are HIV + with CD4 count of < 200 are excluded. Subjects with bacteremia within the past six (6) weeks must have negative blood cultures one week after completing appropriate antibiotic therapy prior to enrollment.
  8. Severe underlying co-morbidity or immediate life-threatening condition.
  9. Subjects with any condition which, in the opinion of the investigator, could preclude evaluation of response or completion of follow-up or affect subject safety.
  10. Subjects with significant arterial occlusive disease which would preclude safe placement of an upper extremity hemodialysis access.
  11. Subjects with history or findings on physical examination suggesting significant arterial insufficiency that could affect patient safety and/or device performance in the extremity planned for use with GVAS (i.e., steal syndrome, hand ischemia, peripheral arterial vascular disease, etc.).
  12. Subjects with scheduled kidney transplant within the next 12 months.
  13. Subjects with history of superior vena cava syndrome are excluded unless it was induced by previous access (these subjects can be enrolled).
  14. Subjects with history of decreased cardiac output with ejection fraction < 20% and/or NYHA class III or IV. NYHA definitions: Class III - Subjects with marked limitation of activity; they are comfortable only at rest; Class IV - Subjects who should be at complete rest, confined to bed or chair; any physical activity brings on discomfort and symptoms occur at rest.
  15. Subjects with history of uncorrected hypotension with systolic blood pressures routinely < 100 mg Hg.
  16. Subjects who currently have a pacemaker or ICD in their central venous system on the same side where the GVAS device would be implanted.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00889564

United States, Florida
University of Miami / Cedars Medical Center
Miami, Florida, United States, 33125
United States, Georgia
St. Joseph's Hospital
Atlanta, Georgia, United States, 30342
United States, Illinois
Southern Illinois University
Springfield, Illinois, United States, 62702
United States, Minnesota
North Memorial Medical Center
Robbinsdale, Minnesota, United States, 55422
United States, South Carolina
Bamberg County Hospital
Bamberg, South Carolina, United States, 29003
United States, Texas
Baptist Medical Center
San Antonio, Texas, United States, 78205
United States, Virginia
Sentara Heart Hospital
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Merit Medical Systems, Inc.
Integra Clinical Trial Solutions - statistical analysis
Ross, John, M.D.
Principal Investigator: John Ross, MD Bamberg County Hospital

Responsible Party: Merit Medical Systems, Inc. Identifier: NCT00889564     History of Changes
Other Study ID Numbers: 11-0050
First Posted: April 29, 2009    Key Record Dates
Last Update Posted: August 8, 2017
Last Verified: August 2017

Keywords provided by Merit Medical Systems, Inc.:
Vascular access for hemodialysis
Catheter dependent patients
Access challenged patients
HeRO Vascular Access Device

Additional relevant MeSH terms:
Bacterial Infections
Systemic Inflammatory Response Syndrome
Pathologic Processes