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Stratos LV/LV-T Technical Manual 17
1.7 Clinical Studies
The subsequent sections summarize the following three clinical
studies that were used to support the safety and effectiveness of
the Stratos LV/LV-T CRT-Ps.
• The AVAIL CLS/CRT clinical study
• The OVID clinical study (OUS)
• The OPTION CRT/ATx clinical study
Two of the studies, AVAIL CLS/CRT and OVID, collected
significant safety data supporting use of the Stratos LV/LV-T
CRT-P system. The third study, OPTION CRT/ATx, supports
the effectiveness of cardiac resynchronization therapy (CRT).
The OPTION CRT/ATx study was conducted on a device that
delivers CRT but, in addition, also offers defibrillation therapy
(CRT-D).
1.7.1 Stratos LV Clinical Study – AVAIL CLS/CRT
Study Design
The AVAIL CLS/CRT was a multi-center, prospective,
randomized, blinded clinical study designed to support approval
for cardiac resynchronization therapy for a Heart Failure (HF)
patient population not requiring back up defibrillation and that are
indicated for an ablate and pace procedures. All patients
enrolled into the clinical study were randomly assigned to one of
three groups using a 2:2:1 ratio for randomization.