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OpenTrials
Completed

NCT Number: NCT02857231

Bioimpedance Spectroscopy Compared to CardioMEMS™

Comparison of changes in diastolic pulmonary artery pressure as measured by CardioMEMS™ to impedance parameters as measured by ImpediMed's BIS technology.

Completed

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Key information

Conditions

NYHA Class III Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Scripps Clinic, John R. Anderson V Medical Pavilion

La Jolla, California, 92037, United States

About this study

This is a prospective, single-arm, observational, non-randomized clinical study that will enroll patients with heart failure who have had a CardioMEMS™ device implanted to monitor their diastolic pulmonary artery pressure. The study will recruit and enroll ten participants from the Scripps Clinic. Participants will be monitored 3 times a week for a period of 4 weeks. At each monitoring visit, the patient's diastolic pulmonary artery pressure will be measured by CardioMEMS™ and the ImpediMed's BIS technology. Participant's vital signs and weight will also be taken at each monitoring visit.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patient:

  • has an CardioMEMs device implanted
  • has been diagnosed with various stages of heart failure as described by New York Heart Association (NYHA)
  • is able to give informed consent

Exclusion criteria

Patient:

  • has pacemaker/ICD
  • is pregnant or breastfeeding
  • is an amputee
  • has been diagnosed with multiple medical conditions that would make participation burdensome
  • not able to co-operate with impedance measurements

Treatment and study plan

Primary outcomes

  1. Change from baseline in bioimpedance measurement at 4 weeks

    Time frame: Baseline and 4 weeks

    Change in impedance values will be tracked from baseline for 4 weeks and compared to CardioMEMS measures

Sponsors and collaborators

Lead sponsor

ImpediMed Limited

Industry

Registry information

Official study title

Bioimpedance Spectroscopy Compared to CardioMEMS™ Determined Pulmonary Artery Pressure Measurements

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 5, 2016
Registry last updated
Jul 8, 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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