Impedance During Cardiac Catheterization to Build a Non-Invasive Cardiac Output Algorithm

July 9, 2025 updated by: Johns Hopkins University

Prospective Measurement of Impedance During Cardiac Catheterization to Build a Non-Invasive Cardiac Output Algorithm

Prospectively measure impedance during cardiac catheterization to build a cardiac output algorithm.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Children's Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Scheduled to undergo cardiac catheterization with cardiac output measurement and Fick
  • Planned to undergo general anesthesia for cardiac catheterization standard of care
  • Parent/Guardian able to provide informed consent

Exclusion Criteria:

  • Not planned for standard of care general anesthesia for cardiac catheterization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Research Prototype Monitor
Device: Research Prototype Monitor
Continuous vital sign is collected via a research prototype monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of a non-invasive monitoring device
Time Frame: From device placement to removal, up to 12 hours
Feasibility of a non-invasive monitoring device that can accurately measure cardiac output in patients with congenital heart disease as determined by percent error compared to catheter-measured cardiac output.
From device placement to removal, up to 12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: Danielle Gottlieb Sen, MD, MPH, Johns Hopkins School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2023

Primary Completion (Actual)

June 24, 2025

Study Completion (Actual)

June 24, 2025

Study Registration Dates

First Submitted

November 28, 2023

First Submitted That Met QC Criteria

December 13, 2023

First Posted (Actual)

December 15, 2023

Study Record Updates

Last Update Posted (Actual)

July 14, 2025

Last Update Submitted That Met QC Criteria

July 9, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00281586

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Congenital Heart Disease

Clinical Trials on Research Prototype Monitor

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe