Bioimpedance Spectroscopy Compared to CardioMEMS™

NYHA Class III Heart Failure Clinical Trial

Official title:

Bioimpedance Spectroscopy Compared to CardioMEMS™ Determined Pulmonary Artery Pressure Measurements

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02857231
• Other study ID #: IPD-SCRIPPS-01
• Status: Completed
• Start date: August 7, 2017
• Est. completion date: October 9, 2018

Study information

• Verified date: July 2019
• Source: ImpediMed Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 9, 2018
• Est. primary completion date: March 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• NYHA Class III Heart Failure

Locations

Country	Name	City	State
United States	Scripps Clinic, John R. Anderson V Medical Pavilion	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
ImpediMed Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in bioimpedance measurement at 4 weeks	Change in impedance values will be tracked from baseline for 4 weeks and compared to CardioMEMS measures	Baseline and 4 weeks