Correlation of SOZO BIS Measures With CardioMEMS PA Pressure



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:9/15/2018
Start Date:August 29, 2017
End Date:August 2019
Contact:Roy Small, MD
Email:small708@supernet.com
Phone:(717) 397-5484

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Correlation of Bioimpedance Measurements From the SOZO Device With Pulmonary Arterial Pressure Measurements From the CardioMEMS HF System

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.

Inclusion Criteria:

1. Age 18 years or older.

2. NYHA Class III HF.

3. Patient has undergone implantation of CardioMEMS HF System (St. Jude Medical).

4. Patient is characterized by at least one of the following:

- CardioMEMS implanted within the previous 90 days

- Received treatment with intravenous diuretics within the previous 30 days

- Received dose escalation of oral diuretics at least twice within the previous 30
days

5. Patient is able to sit upright for BIS measurements.

6. Patient provides written informed consent and authorization to use and disclose health
information.

Exclusion Criteria:

1. Patient is enrolled in a concurrent interventional study of an experimental treatment
that may confound the results of this study, in the investigator's opinion.

2. Patient has a clinical condition that would not allow them to complete the study.

3. Patient is pregnant or lactating.

4. Patient has nephrotic syndrome or nephrosis.

5. Patient has estimated glomerular filtration rate (eGFR) < 20 ml/min/1.73m2 or
end-stage renal disease requiring chronic dialysis.

6. Patient has been diagnosed with lymphedema.

7. Patient has chronic liver failure or cirrhosis.

8. Patient has a moderate or large pleural effusion as seen on chest X-ray.

9. Patient has been diagnosed with thrombophlebitis or deep vein thrombosis in arms or
legs in the past 90 days.

10. Patient has an implanted cardiac rhythm management device (pacemaker or implantable
cardioverter defibrillator).

11. Patient has an amputation of a limb.
We found this trial at
2
sites
Rochester, Minnesota 55905
Principal Investigator: Grace Lin, MD
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555 N Duke St
Lancaster, Pennsylvania 17602
(717) 544-5511
Principal Investigator: Tareck Nossuli
Lancaster General Hospital For more than a century, Lancaster General Hospital has been a leader...
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