Bioimpedance Spectroscopy Compared to CardioMEMS™
- Conditions
- NYHA Class III Heart Failure
- Registration Number
- NCT02857231
- Lead Sponsor
- ImpediMed Limited
- Brief Summary
Comparison of changes in diastolic pulmonary artery pressure as measured by CardioMEMS™ to impedance parameters as measured by ImpediMed's BIS technology.
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
Patient:
- has an CardioMEMs device implanted
- has been diagnosed with various stages of heart failure as described by New York Heart Association (NYHA)
- is able to give informed consent
Patient:
- has pacemaker/ICD
- is pregnant or breastfeeding
- is an amputee
- has been diagnosed with multiple medical conditions that would make participation burdensome
- not able to co-operate with impedance measurements
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in bioimpedance measurement at 4 weeks Baseline and 4 weeks Change in impedance values will be tracked from baseline for 4 weeks and compared to CardioMEMS measures
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Scripps Clinic, John R. Anderson V Medical Pavilion
🇺🇸La Jolla, California, United States