Filter
Top Products
50 Stratos LV/LV-T Technical Manual
Primarily, the study evaluates and compares the functional
benefits of CRT between the two randomized groups using a
composite endpoint consisting of a six-minute walk test (meters
walked) and quality of life measurement (assessed using the
Minnesota Living with Heart Failure Questionnaire). Relevant
measurements were completed twice for each patient: once at
the Baseline evaluation (two-week post implant follow-up) and
again at a six-month follow-up evaluation. The data collected
during this clinical study was used to demonstrate equivalent
treatment of CHF in both the study and control groups. This
study also evaluated other outcomes including: the percentage
of time CRT is delivered, and other measures of CHF status,
including NYHA classification, peak oxygen consumption during
metabolic exercise testing, and the rate of hospitalization for
CHF.
Clinical Inclusion Criteria
To support the objectives of this investigation, patients were
required to meet the following inclusion criteria prior to
enrollment:
• Stable, symptomatic CHF status
• NYHA Class III or IV congestive heart failure
• Left ventricular ejection fraction ≤ 35% (measured within
six-months prior to enrollment)
• Intraventricular conduction delay (QRS duration greater
than or equal to 130 ms)
• For patients with an existing ICD, optimal and stable
CHF drug regimen including ACE-inhibitors and beta-
blockers unless contraindicated (stable is defined as
changes in dosages less than 50% during the last
30 days)
• Indicated for ICD therapy
• History or significant risk of atrial tachyarrhythmias
• Willing to receive possibly uncomfortable atrial shock
therapy for the treatment of atrial tachyarrhythmias
• Able to understand the nature of the study and give
informed consent