Back to resultsREVEAL for Respiration Detection
Primary Purpose
Unexplained Syncope, Suspected Arrhythmia
Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Breathing Exercise Cohort
Sponsored by
About this trial
This is an interventional diagnostic trial for Unexplained Syncope
Eligibility Criteria
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
Sites / Locations
- Diakonessenhuis
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Breathing Exercise Cohort
Arm Description
All patients enrolled will be asked to wear an external respiration band while performing a series of breathing exercises.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01956578
Brief Title
REVEAL for Respiration Detection
Official Title
REVEAL for Respiration Detection
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
November 2013 (Anticipated)
Study Completion Date
November 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic BRC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unexplained Syncope, Suspected Arrhythmia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Breathing Exercise Cohort
Arm Type
Experimental
Arm Description
All patients enrolled will be asked to wear an external respiration band while performing a series of breathing exercises.
Intervention Type
Other
Intervention Name(s)
Breathing Exercise Cohort
Intervention Description
All patients enrolled will be asked to wear a respiration band and perform a series of breathing exercises.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. Bucx
Organizational Affiliation
Diakonessenhuis, Utrecht
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diakonessenhuis
City
Utrecht
ZIP/Postal Code
3508TG
Country
Netherlands
12. IPD Sharing Statement
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REVEAL for Respiration Detection
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