REVEAL for Respiration Detection

Suspected Arrhythmia Clinical Trial

Official title:

REVEAL for Respiration Detection

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01956578
• Other study ID #: REST
• Status: Enrolling by invitation
• Phase: N/A
• First received: September 18, 2013
• Last updated: October 7, 2013
• Start date: September 2013
• Est. completion date: November 2013

Study information

• Verified date: September 2013
• Source: Medtronic BRC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Independent Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 15
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Suspected Arrhythmia
• Unexplained Syncope

Intervention

Other:
• Breathing Exercise Cohort
All patients enrolled will be asked to wear a respiration band and perform a series of breathing exercises.

Locations

Country	Name	City	State
Netherlands	Diakonessenhuis	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic BRC

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No