ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
Medtronic BRC

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.

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)
Primary Purpose: Diagnostic
Official Title: REVEAL for Respiration Detection
Study Start Date : September 2013
Estimated Primary Completion Date : November 2013
Estimated Study Completion Date : November 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
Netherlands
Diakonessenhuis
Utrecht, Netherlands, 3508TG
Sponsors and Collaborators
Medtronic BRC
Investigators
Principal Investigator: J. Bucx Diakonessenhuis, Utrecht

Responsible Party: Medtronic BRC
ClinicalTrials.gov Identifier: NCT01956578     History of Changes
Other Study ID Numbers: REST
First Posted: October 8, 2013    Key Record Dates
Last Update Posted: October 8, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
Syncope
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms