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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All participants | Other | All participants enrolled in a single arm to evaluate effect of variables (posture, respiration, exertion) on pulmonary artery pressure (PAP) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reveal LINQ ICM Cardiac Monitor, taped on the subject's chest rather than inserted in the body. | Other | Cardiac Monitor with LINQ™ HF Investigational RAMware download |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Pulmonary Artery Pressure (PAP) Due to Change in Posture | Posture defined as lying left side down compared to baseline supine | Same day as enrollment (during office visit, maximum of 30 minutes after baseline masurement) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in PAP During Change in Respiration | Outcome measure defined as PAP during coughing compared to PAP during normal breathing respiration at baseline. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Verla Laager | Medtronic | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States | ||
| The Lindner Research Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm Design | Single arm (all participants) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm | Single arm |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change in Pulmonary Artery Pressure (PAP) Due to Change in Posture | Posture defined as lying left side down compared to baseline supine | Only 14 patients able to provide data to contribute to analysis. | Posted | Mean | Standard Deviation | mmHg | Same day as enrollment (during office visit, maximum of 30 minutes after baseline masurement) |
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All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm | Single arm |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Verla Laager | Medtronic Inc | (800) 328.2518 | verla.l.laager@medtronic.com |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Same day as enrollment (during office visit, maximum of 10 minutes after baseline measurement) |
| Cincinnati |
| Ohio |
| 45219 |
| United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Secondary | Change in PAP During Change in Respiration | Outcome measure defined as PAP during coughing compared to PAP during normal breathing respiration at baseline. | Posted | Mean | Standard Deviation | mmHg | Same day as enrollment (during office visit, maximum of 30 minutes after baseline measurement) |
|
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| Secondary | Change in PAP as Measured After Mild Exertion Compared to Initial Baseline PAP at Rest. | Posted | Mean | Standard Deviation | mmHg | Same day as enrollment (during office visit, maximum of 10 minutes after baseline measurement) |
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