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REVEAL for Respiration Detection

NCT ID: NCT01956578

Last Updated: 2013-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2013-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Unexplained Syncope Suspected Arrhythmia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Breathing Exercise Cohort

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

Group Type EXPERIMENTAL

Breathing Exercise Cohort

Intervention Type OTHER

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

Interventions

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Breathing Exercise Cohort

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic BRC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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J. Bucx

Role: PRINCIPAL_INVESTIGATOR

Diakonessenhuis, Utrecht

Locations

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Diakonessenhuis

Utrecht, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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REST

Identifier Type: -

Identifier Source: org_study_id