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Completed

NCT Number: NCT02943941

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco, San Francisco, California, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

Cardiac Monitor with LINQ™ HF Investigational RAMware download

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

Primary outcomes

  1. Mean Change in Pulmonary Artery Pressure (PAP) Due to Change in Posture

    Time frame: Same day as enrollment (during office visit, maximum of 30 minutes after baseline masurement)

    Posture defined as lying left side down compared to baseline supine

Secondary outcomes

  1. Change in PAP During Change in Respiration

    Time frame: Same day as enrollment (during office visit, maximum of 30 minutes after baseline measurement)

    Outcome measure defined as PAP during coughing compared to PAP during normal breathing respiration at baseline.

  2. Change in PAP as Measured After Mild Exertion Compared to Initial Baseline PAP at Rest.

    Time frame: Same day as enrollment (during office visit, maximum of 10 minutes after baseline measurement)

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Official study title

Aquarius Pressure Variability Study

Acronym: APVS

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 25, 2016
Registry last updated
Apr 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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