Pressure Variability Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Aquarius Pressure Variability Study

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Reveal LINQ ICM Cardiac Monitor, taped on the subject's chest rather than inserted in the body.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Investigator believes the patient's condition is sufficiently stable to safely participate in the study procedures Subject is currently implanted with a commercially available pulmonary artery pressure sensor and device communication has been reliable (recent history of successful communications with patient communication system) Exclusion Criteria: Subject has a history of primary PAH
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: All participants<br>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.<br>* Cardiac Monitor with LINQ™ HF Investigational RAMware download<br>* Other names: Interventions included: Changing posture, changing respiration, and changing exertion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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. |  | Same day as enrollment (during office visit, maximum of 10 minutes after baseline measurement) |