Trials / Completed
CompletedNCT02939053
Correlation of SOZO BIS Measures With CardioMEMS PA Pressure
Correlation of Bioimpedance Measurements From the SOZO Device With Pulmonary Arterial Pressure Measurements From the CardioMEMS HF System
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 3 (actual)
- Sponsor
- ImpediMed Limited · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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).
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SOZO | The SOZO device is a bioimpedance spectroscopy device that measures bioimpedance parameters. |
Timeline
- Start date
- 2017-08-29
- Primary completion
- 2018-05-03
- Completion
- 2019-06-25
- First posted
- 2016-10-19
- Last updated
- 2019-07-08
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02939053. Inclusion in this directory is not an endorsement.