Unexplained SyncopeNCT01956578
REVEAL for Respiration Detection
A study testing Breathing Exercise Cohort in people with Unexplained Syncope and Suspected Arrhythmia, run by Medtronic BRC at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unexplained Syncope, Suspected Arrhythmia
- What is being tested?
- Breathing Exercise Cohort
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2013to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Unexplained Syncope, Suspected Arrhythmia
- Being tested
- Breathing Exercise Cohort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing Exercise CohortOther
All patients enrolled will be asked to wear a respiration band and perform a series of breathing exercises.
| Study group | Role | What they receive |
|---|---|---|
| Breathing Exercise Cohort | Experimental | All patients enrolled will be asked to wear an external respiration band while performing a series of breathing exercises. Receives: Other: Breathing Exercise Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 minutes
Secondary outcomes (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.
Measured: Up to 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionNov 2013 (estimated)
- Study completionNov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unexplained SyncopeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic BRC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- J. Bucx, Principal investigator, Diakonessenhuis, Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01956578
- Sponsor's protocol ID
- REST
- Status last verified
- Sep 2013
- First submitted
- 18 Sep 2013
- Last updated
- 8 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REVEAL for Respiration Detection
- ClinicalTrials.gov ID
- NCT01956578
- Acronym / sponsor ID
- REST
- Conditions
- Unexplained Syncope, Suspected Arrhythmia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Medtronic BRCIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breathing Exercise Cohort | Experimental | Other: Breathing Exercise CohortAll patients enrolled will be asked to wear an external respiration band while performing a series of breathing exercises. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breathing Exercise CohortAll patients enrolled will be asked to wear a respiration band and perform a series of breathing exercises. | Other | Breathing Exercise Cohort |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. Bucx principal investigator
Diakonessenhuis, Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing Exercise Cohort in people with Unexplained Syncope and Suspected Arrhythmia, run by Medtronic BRC at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2013.