Heart failure heart rhythm disorder
Conditions
Interventions
During pre-discharge, 6 weeks and 6 month visits patients ave to do a 6 Minute
Walk Test. Also during 6 week visit patients have to do an exercise stress
test.
Sponsors
Sorin Group Nederland N.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - patients implanted with a CRT-D device according to published relevant ESC guidelines in the last 5 days; - patients implanted with an Implantable cardioverter defibrillator (CRT-D) device equipped with SonR technology; - patients implanted with a SonRtip tm right atrial lead; - patients in sinus rhythm; - patients on stable medical therapies regimen; - patients capable to perform stress test; - patients reviewed, sign and dated an informed consent form
Exclusion criteria
Exclusion criteria: patients with: - persistent atrial arrhythmias within the past three months; - unstable angina or acure MI within the past 3 months; - already included in another clinical study that could confound the results of this study - pregnancy; - vulnerable subjects as defined in ISO 14155:2011; - unavailability for scheduled follow-up or refusal to cooperate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is to investigate any relationship between changes in the SonR1 augmentation and a change in the exercise capacity of CRT patients as assessed by the 6MWTbetween follow-ups | — |
Secondary
| Measure | Time frame |
|---|---|
| - Assess that for 10 out of the 15 first patients enrolled the data stored in the SonR histograms can be used to generate an estimate of the SonR augmentation from rest to exercise; - Observe, qualitatively, whether the changes in the SonR1 augmentation curve can be attributed to other measures of functional exercise capacity or cardiac pathologies; - Investigate the relationship between SonR1 amplitude, heart rate, respiratory rate/amplitude and activity level during patients* daily activities; - Observe, qualitatively, any differences in the change of SonR features with heart rate between the ischemic and non-ischemic patients; - Compare the SonR augmentation calculated from the histogram data and that measured from the raw SonR data; - Assess the quality of the MV signal recorded using different lead reference, in different filtering conditions; - Report all the serious adverse events. | — |
Countries
Netherlands
Outcome results
None listed