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Procedure

Research Prototype Monitor for Congenital Heart Disease

N/A

Recruiting

Led By Danielle Gottlieb Sen, MD, MPH

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Planned to undergo general anesthesia for cardiac catheterization standard of care

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from device placement to removal, up to 12 hours

Awards & highlights

Study Summary

This trial will measure heart activity during a heart procedure to create a better way to measure heart output.

Who is the study for?

This trial is for individuals scheduled for cardiac catheterization to measure heart output and who will be under general anesthesia. A parent or guardian must provide consent if the participant is a minor.Check my eligibility

What is being tested?

The study aims to develop a non-invasive method to calculate heart output by measuring impedance during cardiac catheterization using a research prototype monitor.See study design

What are the potential side effects?

Since this trial involves standard care procedures with an additional monitoring device, side effects are likely related to typical risks of cardiac catheterization and anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for a heart procedure under general anesthesia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from device placement to removal, up to 12 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from device placement to removal, up to 12 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and from device placement to removal, up to 12 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility of a non-invasive monitoring device

Trial Design

1Treatment groups

Experimental Treatment

Group I: Research Prototype MonitorExperimental Treatment1 Intervention

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,266 Previous Clinical Trials

14,837,437 Total Patients Enrolled

Danielle Gottlieb Sen, MD, MPHPrincipal InvestigatorJohns Hopkins School of Medicine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current scope of participants in this clinical experiment?

"Affirmative. Clinicaltrials.gov reveals that this clinical research, which was initially published on March 30th 2023, is actively recruiting participants as of December 13th 2023. 1 location needs to find 60 volunteers for the study."

Answered by AI

Are there any current opportunities to participate in this experiment?

"Affirmative. Information on clinicaltrials.gov reveals that this investigation is currently enrolling patients, having first been posted on March 30th 2023 and last amended in December 13th 2023. It seeks to recruit 60 individuals from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Impedance During Cardiac Catheterization to Build a Non-Invasive Cardiac Output Algorithm". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06171698.