An observational study in Coarctation of Aorta, sponsored by University of Minnesota. Active, not recruiting at 7 sites in United States. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2026-04-08.
Sponsored by University of Minnesota · Observational
Coarctation of the aorta accounts for 4-7% of all congenital heart disease. While stent therapy, when feasible, is the standard of care for coarctation, it may not completely improve the work (and afterload) of the heart due to its effects on the elasticity of the aorta. This study will provide the information needed to understand the effects of current management on the cardiac mechanics and work.
49 studies on the registry are indexed under Aortic Coarctation; 16 are open to participants now.
This study's enrollment of 21 is below the median of 100 across 29 observational studies indexed under Aortic Coarctation.
Browse Aortic Coarctation studies →University of Minnesota is the lead sponsor of 1,216 studies on the registry; 197 are open to participants now.
Of its 136 completed or terminated interventional studies of FDA-regulated products, 95 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients referred for elective cardiac catheterization and stent therapy for coarctation
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diagnostic Test: Pressure-volume loop catheter
The cardiac catheterization procedure will be done according to standard protocol as part of the standard clinical care. This has become the standard of care in any patient in which it feasible and is performed with low risk.
Change in left ventricular afterload measured by arterial elastance
Arterial elastance (Ea) is measured by the pressure volume (PV) loop catheter in the left ventricle. The PV loop catheter measures pressure and volume simultaneously during the entire cardiac cycle. Arterial elastance is a measure of ventricular afterload and will be calculated using previously described formula; Ea (arterial elastance): Ea = Pend systole/ SV (where P, is pressure at end systole, and SV is stroke volume). Elastance will be reported as a continuous variable in mmHg/mL with a higher number indicating an increase in elastance and a negative number indicating a decrease in elastance. Change in elastance before and after stent placement will be compared using paired T test.
Time frame: Immediately following intervention
Change in left ventricular performance measured by ESPVR
The end systolic pressure volume relationship (ESPVR) summarizes ventricular systolic function and is measured as a slope of End systolic ventricular elastance (Ees) and volume-axis intercept Vo such that ESP = Ees (ESV-Vo) (ESP = end-systolic pressure, ESV = end-systolic volume, Vo represents the unstressed volume, which is the volume required to fill the ventricle before pressure rises). Shifts of the ESPVR occur with changes in ventricular contractility such that increases in contractility are associated with upward/leftward shifts of the ESPVR. ESPVR is obtained by analysing the data and PV loops obtained by PV loop catheter in the left ventricle before and after intervention. It will be depicted as a continuous variable in mmHg/ml as well as graphically as a slope. Changes before and after intervention will be compared as shifts in ESPVR.
Time frame: Immediately following intervention
Change in left ventricular work as measured by Stroke Work
Stroke work (SW) is a continuous variable that measures the work done by the left ventricle in ejecting blood in one cardiac cycle. It is the area under one loop and is measured in mmHg.ml. SW is obtained by analysing the data and PV loops obtained by PV loop catheter in the left ventricle before and after intervention. SW before and after intervention will be compared as continuous variables using appropriate statistical tests.
Time frame: Immediately following intervention
Change in left ventricular efficiency as measured by ventricular arterial coupling
VA coupling is calculated by the ratio of effective arterial elastance (Ea), a measure of afterload, to LV endsystolic elastance (Ees), a relatively load independent measure of LV chamber performance. Both these measures are expressed in mmHg/ml and as continuous variables. Normal determined Ea and Ees values in resting subjects are 2.2 ± 0.8 mmHg/ml and 2.3 ± 1.0 mmHg/ml, respectively. When Ea/Ees ratio is approximately equal to 1.0, LV and arterial system are optimally coupled to produce stroke work, a measure of the efficiency of LV work, corresponding to the product of systolic arterial pressure and stroke volume, and related to oxygen consumption. When Ea/Ees ratio is \<1.0, the stroke work remains close to optimal values, but when EA/EES ratio is \>1.0, the stroke work significantly falls, and the LV becomes progressively less efficient. We will compare VA coupling before and after intervention and will be analyzed as continuous variables with appropriate statistical tests.
Time frame: Immediately following intervention
Started Jun 2019 (actual). Primary completion is estimated for Dec 2026, 90 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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