Pressure Variability Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-01-31

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.

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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).

Conditions

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Heart Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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All participants

All participants enrolled in a single arm to evaluate effect of variables (posture, respiration, exertion) on pulmonary artery pressure (PAP)

Group Type OTHER

Reveal LINQ ICM Cardiac Monitor, taped on the subject's chest rather than inserted in the body.

Intervention Type OTHER

Cardiac Monitor with LINQ™ HF Investigational RAMware download

Interventions

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Reveal LINQ ICM Cardiac Monitor, taped on the subject's chest rather than inserted in the body.

Cardiac Monitor with LINQ™ HF Investigational RAMware download

Intervention Type OTHER

Other Intervention Names

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Interventions included: Changing posture, changing respiration, and changing exertion

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)