REVEAL for Respiration Detection

Medtronic BRC1 site in 1 country15 target enrollmentSeptember 2013

ConditionsUnexplained Syncope Suspected Arrhythmia

Overview

Phase: N/A
Intervention: Not specified
Conditions: Unexplained Syncope
Sponsor: Medtronic BRC
Enrollment: 15
Locations: 1
Primary Endpoint: Respiration rate derived from the Reveal ICM ECG correlated with the respiration rate from the external respiratory band during a three minute period of normal breathing.
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study will evaluate the correlation between the respiratory rate derived from the Reveal Insertable Cardiac Monitor (ICM) electrocardiogram (ECG) with the respiratory rate obtained from an external respiratory band in patients previously implanted with a Reveal for unexplained syncope or suspected arrhythmia.

Registry

clinicaltrials.gov

Start Date

September 2013

End Date

November 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Medtronic BRC

Responsible Party

Sponsor

Eligibility 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 or as specified minimal age per local law/regulation

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 respiration 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

Outcomes

Primary Outcomes

Respiration rate derived from the Reveal ICM ECG correlated with the respiration rate from the external respiratory band during a three minute period of normal breathing.

Time Frame: Up to 3 minutes

Secondary Outcomes

Respiration rate obtained from the REVEAL ICM ECG with the respiratory rate obtained from external respiratory band during three minute periods of periodic, controlled breathing and elevated heart rate.(Up to 3 minutes)