Cardiomyopathy Heart failure
Conditions
Interventions
Group 1 has optimalization of A-V and V-V delays using Quickopt at 3, 6, 9 and
12 months after implantation.
Group 2 has a one time only optimalization of the A-V and V-V delays according
to the sta
Sponsors
St. Jude Medical
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Patient meets current CRT-D indications and be implanted with an SJM CRT-D device with V-V timing and a compatible lead system. • Patient has the ability to complete a 6-minute hall walk with the only limiting factor to be fatigue or shortness of breath. • Patient is geographically stable and willing to comply with the required follow-up schedule. • Adequate echocardiographic images to measure LV end systolic volume
Exclusion criteria
Exclusion criteria: • Patient has an epicardial ventricular lead system. • Patient has the ability to walk >= 450 meters in 6 minutes • Patient has limited intrinsic atrial activity (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A combination of symptomatic improvement (>= 1 class reduction in specific activity scale or >= 25% improvement in 6 minute walk test distance) and LV remodeling (>= 15% decrease of LV end systolic volume or >= 5% increase in LV EF). | — |
Secondary
| Measure | Time frame |
|---|---|
| • Rate of late (12-month) response to CRT • Changes in BNP in correlation to cardiac remodeling • Inter- / intra-ventricular dyssynchrony compared to usual optimization | — |
Countries
Netherlands
Outcome results
None listed