Heart Failure
Conditions
Interventions
None listed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - patient meets current CRT-D indications and be impanted with an SJM CRT-D device with V-V timing and a compatible lead system - patient had the ability to complete a 6-minute hall walk with the only limiting factor to be fatique of shortness of breath. - patient older than 18 year.
Exclusion criteria
Exclusion criteria: - patient is less than 18 years old. - patient has persistent of permanent AF. - patient has the ability to walk > 450 meters in 6 minutes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this clinical investigation is to demonstrate that the proportion of improved patients in the treatment group is superior to the proportion in the control group, 12 months post-implantation. The Heart Failure Clinical Composite Response22 will be used to evaluate the status of the patient. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives of the study are: * All-cause, cardiovascular and heart failure mortality; * All-cause, cardiovascular and heart failure hospitalizations. | — |
Countries
Netherlands
Outcome results
None listed