REVEAL for Respiration Detection
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01956578|
Recruitment Status : Unknown
Verified September 2013 by Medtronic BRC.
Recruitment status was: Enrolling by invitation
First Posted : October 8, 2013
Last Update Posted : October 8, 2013
|Condition or disease||Intervention/treatment||Phase|
|Unexplained Syncope Suspected Arrhythmia||Other: Breathing Exercise Cohort||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||REVEAL for Respiration Detection|
|Study Start Date :||September 2013|
|Estimated Primary Completion Date :||November 2013|
|Estimated Study Completion Date :||November 2013|
Experimental: Breathing Exercise Cohort
All patients enrolled will be asked to wear an external respiration band while performing a series of breathing exercises.
Other: Breathing Exercise Cohort
All patients enrolled will be asked to wear a respiration band and perform a series of breathing exercises.
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01956578
|Utrecht, Netherlands, 3508TG|
|Principal Investigator:||J. Bucx||Diakonessenhuis, Utrecht|