UnknownNot Applicable

REVEAL for Respiration Detection

Netherlands15 participantsStarted 2013-09

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

Timeframe: Up to 3 minutes

Trial details

NCT IDNCT01956578

SponsorMedtronic BRC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-11

View on ClinicalTrials.gov More Unexplained Syncope trials