REVEAL for Respiration Detection (REST)

Withdrawn

Conditions: syncope met onbekende oorzaak
cardiac monitor
respiration
10007521

Registration Number: NL-OMON38837

Lead Sponsor: Medtronic B.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 15

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

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

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>During the study all hemodynamic and electrophysiological data is continuously<br /><br>collected via the holter and respiration band downloads. The primary endpoint<br /><br>for this study is the correlation between the respiratory rate obtained from<br /><br>the ICM ECG and the external respiratory band during normal breathing.<br /><br><br /><br>The respiration effects the heart rate such that the heart rate increases<br /><br>during inspiration and decreases during expiration, the fluctuations are<br /><br>extracted from the Reveal ECG by measuring the distance between the R peaks<br /><br>(from the QRS complex) and used to create a time series, a band-width filter is<br /><br>applied to the time series, then two statistical techniques are used to<br /><br>calculate the respiration rate - an autoregressive model and an empirical mode<br /><br>decomposition model. </p><br>

Secondary Outcome Measures