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

NCT06171698 | Withdrawn

• 1 other identifier: IRB00281586
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

• Feasibility of a non-invasive monitoring device

  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

Study Arms (1)

Research Prototype Monitor

EXPERIMENTAL

Device: Research Prototype Monitor

Interventions

Research Prototype Monitor DEVICE

Continuous vital sign is collected via a research prototype monitor

Research Prototype Monitor

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Children's Center

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Danielle Gottlieb Sen, MD, MPH

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 15, 2023
• Study Start: March 30, 2023
• Primary Completion: June 24, 2025
• Study Completion: June 24, 2025
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)