Low-Density Lipoprotein (LDL) Apheresis Using H.E.L.P. Therapy
Condition: Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Intervention: HELP Secura (apheresis treatment)
Intervention description: Process is described in Arm (above).
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 113.0
Sex: All
Healthy volunteers: No
Keywords: Hypercholesterolemia; FH; LDL-C; CHD

Summary:

      The objectives of this post-surveillance study are to continue to evaluate the safety and
      effectiveness of the H.E.L.P. System. The safety and effectiveness will be assessed by
      evaluating the occurrence of death, cardiovascular events or interventions, angina, and
      serious unanticipated adverse effects. Laboratory assessments will be made to document
      low-density lipoprotein cholesterol (LDL-C) reduction and any effects on other blood
      components. Quality of life assessments will also be made.

      The study will also assess the modifications to the H.E.L.P. System, including:

        -  use of a single heparin adsorber, instead of two smaller adsorbers;

        -  change in the supplier of the ultrafilter (from Secon to Toray);

        -  reduction in the number of blood lines from eleven to nine;

        -  change from a single-layer to a two-layer precipitate filter.

      The safety and efficacy of the device specific to these modifications will be evaluated by
      comparing the safety and efficacy data from the patient registry to the data from the initial
      clinical study on the device as originally designed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adequate venous access

          -  Laboratory values:

               -  Hematocrit 30% or greater

               -  platelet count between 100,000 and 1,000,000/ml

          -  Premenopausal women must be surgically sterilized or be on oral contraceptive therapy
             and have a negative pregnancy test at the onset of treatment with H.E.L.P.

          -  Patients have familial hypercholesterolemia and have undergone at least 6 months
             optimal diet and drug therapy and fit group A, B, or C

        Exclusion Criteria:

          -  Presence of any of the following conditions:

               -  untreated hypothyroidism

               -  decompensated congestive heart failure

               -  major arrhythmia

               -  uncontrolled diabetes mellitus

               -  any malignancy

               -  disorders associated with excessive bleeding (e.g., peptic ulcer and hemophilia)

               -  established or suspected intracranial disease which might cause intracranial
                  bleeding if the patient is anticoagulated

               -  any other medical disorders which lead the treating physician to believe that
                  H.E.L.P. treatment would not be in the best interest of the patient

               -  current treatment with anticoagulants

               -  diastolic BP > 100 mmHg recorded in two occasions at least 24 hours apart.

               -  patients under 18 years of age

               -  positive test for Hepatitis [Type A (IgM) or B] antigen, Hepatitis C antibody, or
                  HIV (or diagnosis of AIDS)