REVEAL for Respiration Detection

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01956578

Enrollment

Registered

2013-10-08

Start date

2013-09-30

Completion date

2013-11-30

Last updated

2013-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suspected Arrhythmia, Unexplained Syncope

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.

Interventions

OTHERBreathing Exercise Cohort

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026