REVEAL for Respiration Detection

Not Applicable

• Conditions: Unexplained Syncope; Suspected Arrhythmia
• Interventions: Other: Breathing Exercise Cohort

• Registration Number: NCT01956578
• Lead Sponsor: Medtronic BRC

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-09
• Study Start: 2013-09
• Study First Submitted: 2013-09-18
• Study First Submitted QC: 2013-10-07
• Last Update Submitted: 2013-10-07
• Study First Posted: 2013-10-08
• Last Update Posted: 2013-10-08
• Primary Completion: 2013-11
• Study Completion: 2013-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• 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 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Breathing Exercise Cohort	Breathing Exercise Cohort	All patients enrolled will be asked to wear an external respiration band while performing a series of breathing exercises.

Primary Outcome Measures

Name	Time	Method
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.	Up to 3 minutes

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Diakonessenhuis; 🇳🇱 Utrecht, Netherlands