REVEAL for Respiration Detection

NCT01956578 | Unknown

• 1 other identifier: REST
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Unexplained Syncope; Suspected Arrhythmia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Breathing Exercise Cohort

EXPERIMENTAL

All patients enrolled will be asked to wear an external respiration band while performing a series of breathing exercises.

Other: Breathing Exercise Cohort

Interventions

Breathing Exercise Cohort OTHER

All patients enrolled will be asked to wear a respiration band and perform a series of breathing exercises.

Breathing Exercise Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic BRC: lead

Study Sites (1)

Diakonessenhuis

Utrecht, 3508TG, Netherlands

Location

Study Officials

• J. Bucx

  Diakonessenhuis, Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2013
• First Posted: October 8, 2013
• Study Start: September 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: October 8, 2013

Record last verified: 2013-09

Locations

NL (1)