An observational study in NYHA Class III Heart Failure, sponsored by ImpediMed Limited. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-08.
Sponsored by ImpediMed Limited · Observational
This study aims to establish the degree to which change in the ratio of ECF to TBW measured using the SOZO BIS device correlates with change in end-expiratory end-diastolic PAP measured using the CardioMEMS HF System (St. Jude Medical).
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 thirty participants. Participants will be monitored daily at home for a period of 30 days. Each day, the patient's diastolic pulmonary artery pressure will be measured by CardioMEMS™ and the ImpediMed's BIS technology. Participant's weight will also be taken each day.
ImpediMed Limited is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Heart failure patients who have a cardioMEMS device
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patient is characterized by at least one of the following:
Exclusion Criteria:
All subjects enrolled will undergo measurements with the SOZO device daily for 30 days.
Device: SOZO
The SOZO device is a bioimpedance spectroscopy device that measures bioimpedance parameters.
Change in the ratio of whole body ECF/TBW measured using the SOZO BIS device
Changes of body fluid levels in heart failure patients
Time frame: From baseline through study completion, an average of 30 days
Change in the ratio of thoracic ECF/TBW
Changes of thoracic fluid levels in heart failure patients
Time frame: From baseline through study completion, an average of 30 days
Change in the ratio of lower extremity ECF/TBW
Changes of lower limb fluid levels in heart failure patients
Time frame: From baseline through study completion, an average of 30 days
Plan to share: No — This is a pilot study, no individual participant data will be made available.
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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ImpediMed Limited