REVEAL for Respiration Detection

N/AUnknownNCT01956578

Medtronic BRC15 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Unexplained Syncope Suspected Arrhythmia

Interventions

Breathing Exercise CohortOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Diakonessenhuis

Utrecht, Netherlands

Outcomes

Primary Outcomes

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.

Time frame: Up to 3 minutes

Secondary Outcomes

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.

Time frame: Up to 3 minutes

Data from ClinicalTrials.gov

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