Heart Failure Clinical Trial

Pressure Variability Study

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.

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Full Description

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 LINQâ„¢ 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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Eligibility Criteria

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

Study is for people with:

Heart Failure

Estimated Enrollment:

16

Study ID:

NCT02943941

Recruitment Status:

Completed

Sponsor:

Medtronic Cardiac Rhythm and Heart Failure

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There are 2 Locations for this study

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University of California, San Francisco
San Francisco California, 94143, United States
The Lindner Research Center
Cincinnati Ohio, 45219, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

16

Study ID:

NCT02943941

Recruitment Status:

Completed

Sponsor:


Medtronic Cardiac Rhythm and Heart Failure

How clear is this clinincal trial information?

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