Heart Failure Clinical Trial
Official title:
Aquarius Pressure Variability Study
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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