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Correlation of SOZO BIS Measures With CardioMEMS PA Pressure | Clinical Trials | Clareo Health

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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

NCT02939053•ImpediMed Limited

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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).
+1 more criteria

Locations (2)

Mayo Clinic

Rochester, Minnesota, United States

Lancaster General Hospital

Lancaster, Pennsylvania, United States

Key Dates

Start Date

August 29, 2017

Primary Completion Date

May 3, 2018

Completion Date

June 25, 2019

Last Updated

July 8, 2019

Enrollment

ACTUAL participants

Conditions

NYHA Class III Heart Failure

Interventions

SOZO

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 8, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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