An interventional study of Reveal LINQ ICM Cardiac Monitor, taped on the subject's chest rather than inserted in the body. in Heart Failure, sponsored by Medtronic Cardiac Rhythm and Heart Failure. Completed at 2 sites in United States. Per ClinicalTrials.gov, last updated 2019-04-12.
Sponsored by Medtronic Cardiac Rhythm and Heart Failure · Not applicable, Interventional, and Basic science
The purpose of this study is to understand how the pressure in the pulmonary artery changes under different conditions of posture, respiration and exertion.
This is a prospective, multi-center, observational study with enrollment up to 30 subjects at 2 U.S. sites. All study data can be collected on a single day as a one-time visit (lasting approximately 90-120 minutes).
This study is a Non-Significant Risk (NSR) Investigational Device Exemption (IDE) study as LINQ™ HF investigational RAMware is required to activate additional sensors in the Reveal LINQ ICM.
The patient will come to the clinic for a single in-office visit. PA pressure will be measured while the patient is in a variety of positions and during different respiratory exercises and after brief exertion. Data will be collected on eCRFs.
The effects of the different postures, respiration and exertion will be quantified using descriptive statistics (mean, standard deviation).
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 16 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Medtronic Cardiac Rhythm and Heart Failure is the lead sponsor of 239 studies on the registry; 6 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 17 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All participants enrolled in a single arm to evaluate effect of variables (posture, respiration, exertion) on pulmonary artery pressure (PAP)
Other: Reveal LINQ ICM Cardiac Monitor, taped on the subject's chest rather than inserted in the body.
Cardiac Monitor with LINQ™ HF Investigational RAMware download
Also known as: Interventions included: Changing posture, changing respiration, and changing exertion
Mean Change in Pulmonary Artery Pressure (PAP) Due to Change in Posture
Posture defined as lying left side down compared to baseline supine
Time frame: Same day as enrollment (during office visit, maximum of 30 minutes after baseline masurement)
Change in PAP During Change in Respiration
Outcome measure defined as PAP during coughing compared to PAP during normal breathing respiration at baseline.
Time frame: Same day as enrollment (during office visit, maximum of 30 minutes after baseline measurement)
Change in PAP as Measured After Mild Exertion Compared to Initial Baseline PAP at Rest.
Time frame: Same day as enrollment (during office visit, maximum of 10 minutes after baseline measurement)
| Milestone | Single Arm Design |
|---|---|
| Started | 16 |
| Completed | 16 |
| Not completed | 0 |
Posture defined as lying left side down compared to baseline supine
| mmHg | Single Arm Design |
|---|---|
| Mean Change in Pulmonary Artery Pressure (PAP) Due to Change in Posture | 27.7 ± 10.3 |
Outcome measure defined as PAP during coughing compared to PAP during normal breathing respiration at baseline.
| mmHg | Single Arm |
|---|---|
| Change in PAP During Change in Respiration | 25.9 ± 13.3 |
| mmHg | Single Arm Design |
|---|---|
| Change in PAP as Measured After Mild Exertion Compared to Initial Baseline PAP at Rest. | 27.7 ± 12.2 |
Collected over All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single Arm | — | — | — |
| Age, Categorical(Participants) | Single Arm |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 4 |
| >=65 years | 12 |
| Age, Continuous(years) | Single Arm |
|---|---|
| Mean | 68.8 ± 11.2 |
| Sex: Female, Male(Participants) | Single Arm |
|---|---|
| Female | 6 |
| Male | 10 |
| Region of Enrollment(Participants) | Single Arm |
|---|---|
| United States | 16 |
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Medtronic Cardiac Rhythm and Heart Failure