RecruitingNot Applicable

Ventripoint Single Ventricle Study

United States100 participantsStarted 2022-07-08

Plain-language summary

This study will validate a coordinate-based 3-dimensional echocardiographic technique for the assessment of cardiac size and function in children and young adults with functional single ventricles.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * All patients with functional single ventricles will be included, regardless of age or surgical palliation stage, who have had or are having a clinically ordered transthoracic echocardiogram and/or cardiac MRI. Exclusion Criteria: * Patients with congenital heart disease other than functional single ventricles, patients with single ventricle physiology (but not single ventricle anatomy) following a biventricular conversion pathway, or patients unable to understand or consent in English will be excluded.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cardiac function of the right ventricle as measured by ejection fraction

Timeframe: Day 1

Cardiac function of the left ventricle as measured by ejection fraction

Timeframe: Day 1

Right ventricular dimension as measured by end diastolic volume

Timeframe: Day 1

Right ventricular dimension as measured by end systolic volume

Timeframe: Day 1

Left Ventricular Dimension as measured by end diastolic volume

Timeframe: Day 1

Left Ventricular Dimension as measured by end systolic volume

Timeframe: Day 1

Left Ventricular Dimension as measured by end diastolic diameter

Timeframe: Day 1

Trial details

NCT IDNCT05262907

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-08

Contact for this trial

Joan Wilson

999999999 joan.wilson@duke.edu

View on ClinicalTrials.gov More Congenital Heart Disease trials

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Cardiac function of the right ventricle as measured by ejection fraction

Timeframe: Day 1

Cardiac function of the left ventricle as measured by ejection fraction

Timeframe: Day 1

Right ventricular dimension as measured by end diastolic volume

Timeframe: Day 1

Right ventricular dimension as measured by end systolic volume

Timeframe: Day 1

Left Ventricular Dimension as measured by end diastolic volume

Timeframe: Day 1

Left Ventricular Dimension as measured by end systolic volume

Timeframe: Day 1

Left Ventricular Dimension as measured by end diastolic diameter

Timeframe: Day 1