|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P940016 / PAS001 |
| Date Original Protocol Accepted |
09/19/1997
|
| Date Current Protocol Accepted |
09/19/1997
|
| Study Name |
Registry
|
| Device Name |
H.E.L.P. SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This study is a multicenter patient registry. All patients who receive H.E.L.P. therapy will be enrolled into the study. Data for all patients will be collected, a mortality report will be submitted quarterly, and a report including all other data collected (demographic and clinical) will be submitted annually to the FDA. There is no hypothesis to test for this PAS.
|
| Study Population |
All patients who are treated with the Heparin-Induced Extracorporeal Lipoprotein Precipitation (H.E.L.P.) System. H.E.L.P. is a low density lipoprotein cholesterol (LDL-C) apheresis system, indicated for use in performing LDL-C apheresis to acutely remove LDL-C from the plasma of the following high risk patient populations for whom diet has been ineffective and maximum drug therapy has either been ineffective or not tolerated: Group A - Functional Hypercholesterolemic Homozygotes with LDL-C > 500 mg/dl; Group B - Functional Hypercholesterolemic Heterozygotes with LDL-C > 300 mg/dl; and Group C - Functional Hypercholesterolemic Heterozygotes with LDL-C > 200 mg/dl and documented coronary heart disease (CHD).
Documented CHD is defined as having one or more of the following: a prior documented myocardial infarction (MI); a prior coronary artery bypass graft surgery (CABG); a prior percutaneous transluminal coronary angioplasty (PTCA) with or without atherectomy or coronary artery stent placement; and significant angina pectoris with a positive thallium or other heart scanning stress test.
|
| Sample Size |
N/A
|
| Key Study Endpoints |
Data Collection includes: Occurrence of death (cardiovascular or non-cardiovascular deaths); Occurrence of cardiovascular events (MI, stroke, unstable angina, transient ischemic attack (TIA), congestive heart failure, pulmonary embolism, arrhythmia, peripheral vascular disease, hypertension); Occurrence of surgical or non-surgical intervention procedure or the treatment of artherosclerotic cardiovascular disease (eg. CABG). Frequency and severity of CHD symptoms, Use of CHD medications for treatment of the following: angina, heart failure, arrhythmias, hypertension, hyperlipidemia, Use of lipid-lowering medications and other cardiovascular medications concomitantly, Laboratory assessments: lipids, lipoprotein, CBC, Activated clotting time
Coagulation labs, blood chemistry , Quality of life assessments (SF-36), Occurrence of serious or unanticipated adverse events reported during treatment, Occurrence of other serious illnesses, Full physical exam ,Pregnancy test (females), smoking history
|
| Follow-up Visits and Length of Follow-up |
Any patients receiving at least 3 months of H.E.L.P. therapy will be followed for two years after discontinuation of therapy.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
113
|
| Actual Number of Sites Enrolled |
6
|
| Patient Follow-up Rate |
N/A
|
| Final Safety Findings |
No adverse events occurred more tan 1%, but there were 148 AEs, 49% being device related. Sufficient evidence of safety over the 10 years of the study.
|
| Final Effect Findings |
The device lowered cholesterol at least 50% on average
|
| Study Strengths & Weaknesses |
Strengths, all those exposed to device were included in the registry, weaknesses, no specified hypotheses, no sample size calculation, no comparator
|
| Recommendations for Labeling Changes |
none
|
