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| Name | Class |
|---|---|
| Baim Institute for Clinical Research | OTHER |
| Scripps Health | OTHER |
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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 CardioMEMSâ„¢ 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 CardioMEMSâ„¢ and the ImpediMed's BIS technology. Participant's weight will also be taken each day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-arm | All subjects enrolled will undergo measurements with the SOZO device daily for 30 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOZO | Device | The SOZO device is a bioimpedance spectroscopy device that measures bioimpedance parameters. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the ratio of whole body ECF/TBW measured using the SOZO BIS device | Changes of body fluid levels in heart failure patients | From baseline through study completion, an average of 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the ratio of thoracic ECF/TBW | Changes of thoracic fluid levels in heart failure patients | From baseline through study completion, an average of 30 days |
| Change in the ratio of lower extremity ECF/TBW |
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Inclusion Criteria:
Age 18 years or older.
NYHA Class III HF.
Patient has undergone implantation of CardioMEMS HF System (St. Jude Medical).
Patient is characterized by at least one of the following:
Patient is able to sit upright for BIS measurements.
Patient provides written informed consent and authorization to use and disclose health information.
Exclusion Criteria:
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Heart failure patients who have a cardioMEMS device
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| Name | Affiliation | Role |
|---|---|---|
| Roy Small, MD | Lancaster General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States | ||
| Lancaster General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33898536 | Derived | Accardi AJ, Matsubara BS, Gaw RL, Daleiden-Burns A, Heywood JT. Clinical Utility of Fluid Volume Assessment in Heart Failure Patients Using Bioimpedance Spectroscopy. Front Cardiovasc Med. 2021 Apr 7;8:636718. doi: 10.3389/fcvm.2021.636718. eCollection 2021. |
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This is a pilot study, no individual participant data will be made available.
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Changes of lower limb fluid levels in heart failure patients
| From baseline through study completion, an average of 30 days |
| Lancaster |
| Pennsylvania |
| 17603 |
| United States |