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Summary

at San Fransisco, California and other locations
study started
estimated completion:

Description

Summary

The purpose of this study is to understand how the pressure in the pulmonary artery changes under different conditions of posture, respiration and exertion.

Official Title

Aquarius Pressure Variability Study

Details

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).

Keywords

Heart Failure

Eligibility

You can join if…

  • 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)

You CAN'T join if...

  • Subject has a history of primary PAH

Locations

  • University of California, San Francisco not yet accepting patients
    San Fransisco, California, 94143, United States
  • The Lindner Research Center accepting new patients
    Cincinnati, Ohio, 45219, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
ID
NCT02943941
Study Type
Observational
Last Updated
October 2016
I’m interested in this study!