REVEAL for Respiration Detection

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.

Study Overview

• Status: Unknown
• Conditions: Unexplained Syncope; Suspected Arrhythmia
• Intervention / Treatment: Other: Breathing Exercise Cohort

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Utrecht, Netherlands, 3508TG
    • Diakonessenhuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Breathing Exercise Cohort; All patients enrolled will be asked to wear an external respiration band while performing a series of breathing exercises.	Other: Breathing Exercise Cohort; All patients enrolled will be asked to wear a respiration band and perform a series of breathing exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Medtronic BRC
• Investigators: Principal Investigator: J. Bucx, Diakonessenhuis, Utrecht

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (ANTICIPATED): November 1, 2013
• Study Completion (ANTICIPATED): November 1, 2013

Study Registration Dates

• First Submitted: September 18, 2013
• First Submitted That Met QC Criteria: October 7, 2013
• First Posted (ESTIMATE): October 8, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): October 8, 2013
• Last Update Submitted That Met QC Criteria: October 7, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Unconsciousness; Consciousness Disorders; Syncope
• Other Study ID Numbers: REST (Teva)