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52 Stratos LV/LV-T Technical Manual
Follow-Up Schedule
After successful enrollment, all patients were randomly assigned
to either the study group or the control group. The specific
procedures of this study were:
• Pre-enrollment screening
• Randomization
• System implantation
• Pre-discharge follow-up
• Baseline evaluation / CRT activation
• One-Month follow-up
• Three-Month follow-up
• Six-Month follow-up
• Subsequent routine follow-ups (every three months)
Clinical Endpoints
Primary Endpoint 1: Six Minute Walk Test & QOL (Effectiveness)
The purpose of Primary Endpoint 1 is to evaluate the
effectiveness of the Tupos LV/ATx system in providing CRT as
measured by the average composite rate of improvement in six
minute walk test and QOL.
Secondary Endpoint Results
1. The purpose of this secondary endpoint is to evaluate
improvement in functional capacity as measured by the six
minute walk test. The six minute walk test is a well-accepted
measure of functional capacity and exercise tolerance. Also,
this test more closely mimics the patient’s day-to-day
activities than maximal exercise testing.
2. The purpose of this secondary endpoint is to evaluate the
improvement in the patient’s NYHA classification.
Accountability of PMA Cohorts
After randomization and enrollment, 7 patients (4 in the study
group and 3 in the control group) did not receive an implant. The
reasons for patients not receiving an implant are outlined in
Figure 2
.