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.