Bioimpedance Spectroscopy Compared to CardioMEMS™

ImpediMed

Status: Completed

Conditions: NYHA Class III Heart Failure

Study type: Observational

Funder types: Industry

Identifiers

NCT02857231

IPD-SCRIPPS-01

Details and patient eligibility

About

Comparison of changes in diastolic pulmonary artery pressure as measured by CardioMEMS™ to impedance parameters as measured by ImpediMed's BIS technology.

Full 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 ten participants from the Scripps Clinic. Participants will be monitored 3 times a week for a period of 4 weeks. At each monitoring visit, the patient's diastolic pulmonary artery pressure will be measured by CardioMEMS™ and the ImpediMed's BIS technology. Participant's vital signs and weight will also be taken at each monitoring visit.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patient:

1. has an CardioMEMs device implanted
2. has been diagnosed with various stages of heart failure as described by New York Heart Association (NYHA)
3. is able to give informed consent

Exclusion criteria

Patient:

1. has pacemaker/ICD
2. is pregnant or breastfeeding
3. is an amputee
4. has been diagnosed with multiple medical conditions that would make participation burdensome
5. not able to co-operate with impedance measurements