Low-Density Lipoprotein (LDL) Apheresis Using H.E.L.P. Therapy (Secura)
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.
|Familial Hypercholesterolemia||Device: HELP Secura (apheresis treatment)||Phase 4|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Post Marketing Surveillance Study for LDL Apheresis Using H.E.L.P. Therapy|
- Occurence of Death [ Time Frame: Participants were followed for one (1) year following discontinuation of treatment. ]The Categories listed in the table are the Adverse Events (or similar) that resulted in death.
- Occurrence of Cardiovascular Events and Interventions [ Time Frame: Participants were followed for one (1) year following discontinuation of treatment. ]Adverse Events reported for Cardiovascular disease not directly related to therapy.
- Serious Unexpected Adverse Events [ Time Frame: Participants were followed for one (1) year following discontinuation of treatment. ]
- Frequency and Severity of CHD Symptoms (Angina) [ Time Frame: Participants were followed for one (1) year following discontinuation of treatment. ]This is equatable to the incidence of Cardiovascular AEs.
|Study Start Date:||December 1999|
|Study Completion Date:||September 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
Experimental: H.E.L.P. Secura
The H.E.L.P. System is a device composed of multiple modules and their associated disposables which can selectively and continuously remove LDL-cholesterol from plasma by precipitating the LDL-cholesterol with high concentrations of heparin in an acidic buffer and returning the plasma to the patient. Procedure steps:
Device: HELP Secura (apheresis treatment)
Process is described in Arm (above).
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