syncope met onbekende oorzaak cardiac monitor respiration
Conditions
Interventions
None listed
Sponsors
Medtronic B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Subject is implanted with a Reveal ICM or Reveal XT ICM for unexplained syncope or suspected arrhythmia Subject (or the legal representative) is willing to sign informed consent form Subject is 18 years or older
Exclusion criteria
Exclusion criteria: Significant respiratory diseases such as COPD or pulmonary hypertension. Patients with frequent arrhythmias, including PVC*s. Patients with known heart failure. Body conditions that would complicate accurate measurement of respiratory rate with the MediByte device Patients which are not able to take the postures as necessary for the study protocol and which cannot walk continuously for a period of 6 minutes Pregnant or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth control Subject is enrolled in one or more concurrent studies that would confound the results of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| During the study all hemodynamic and electrophysiological data is continuously collected via the holter and respiration band downloads. The primary endpoint for this study is the correlation between the respiratory rate obtained from the ICM ECG and the external respiratory band during normal breathing. The respiration effects the heart rate such that the heart rate increases during inspiration and decreases during expiration, the fluctuations are extracted from the Reveal ECG by measuring the distance between the R peaks (from the QRS complex) and used to create a time series, a band-width filter is applied to the time series, then two statistical techniques are used to calculate the respiration rate - an autoregressive model and an empirical mode decomposition model. | — |
Countries
Netherlands
Outcome results
None listed