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Aortic Valve Dynamics During Exercise After Valve Sparing Root Replacement Surgery

Aortic Valve Dynamics During Exercise After Valve Sparing Root Replacement Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04205474
Enrollment
20
Registered
2019-12-19
Start date
2019-12-16
Completion date
2021-01-01
Last updated
2022-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aneurysm Aortic Root, Aortic Valve, Bicuspid

Keywords

valve sparing procedure, reimplantation

Brief summary

Aortic valve sparing operations are applied in patients with a non-calcified tricuspid or bicuspid aortic valve associated with a root aneurysm, in order to preserve the valve, and avoid new aortic dilatation by stabilizing the aortic valve anulus with a graft prosthesis. This results in a normal functioning aortic valve, with a low forward gradient across the left ventricular outflow tract. Little is known about how the repaired aortic valve behaves in conditions of controlled exercise, and how the gradients across the valve change during exercise.

Detailed description

In a cohort of patients operated on since 2000 with a valve sparing operation for aortic root aneurysm in the Department of Cardiac surgery of the University Hospital Ghent, Belgium, and with gradients at rest across the aortic valve of \<20mmHg, a graded exercise test on a bicycle (stepwise increase of afterload) will be performed, and the gradient across the aortic valve will be monitored by transthoracic echocardiography at each exercise level. Patients with tricuspid and bicuspid valves will be compared. An age matched, unoperated, and asymptomatic control group with normal functioning tricuspid and bicuspid valves will be examined with the same exercise protocol. The purpose of the study is the description of the gradients across the aortic valve during exercise, and the discrimination of risk factors that may induce increased gradients. The hypothesis is that patients with bicuspid valves will demonstrate higher gradients than patients with tricuspid valves, in operated and unoperated individuals.

Interventions

DIAGNOSTIC_TESTgraded bicycle test

the subjects perform an exercise test on a reclining bicycle, and perform against increasing afterload

Sponsors

University Hospital, Ghent
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* been operated with a valve sparing root procedure in the University Hospital Ghent, Belgium, since 2000 * being able to perform an exercise test on a reclining bicycle * normal left ventricular function

Exclusion criteria

* \<18 years or \>60 years of age * peak gradient across the aortic valve at rest of \>20mmHg * decreased left ventricular function

Design outcomes

Primary

MeasureTime frameDescription
Echocardiographic gradients in mmHg and velocity across the aortic valve in m/sec at each exercise levelfrom 1 year postoperativelyobtained with transthoracic echocardiography during exercise- echocardiographic flow velocity across the aortic valve (colour flow Doppler) and in the left ventricular outflow tract (pulsed-wave Doppler) were measured at regular time intervals during grade exercise, and during recovery - examination was recorded digitally
comparison between peak gradients in mmHg across tricuspid and bicuspid aortic valvesfrom 1 year postoperativelyobtained with transthoracic echocardiography during exercise, at each exercise level

Secondary

MeasureTime frameDescription
comparison between gradients across aortic valve in unoperated and operated patients1 yeargradients in mmHg across the aortic valve, measured by transthoracic echocardiography, at increasing afterload levels, on a reclining bicycle

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026