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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04205474
Study type Interventional
Source University Hospital, Ghent
Contact
Status Completed
Phase N/A
Start date December 16, 2019
Completion date January 1, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT03139786 - Follow-up of a Cohort of Patients With Aortic Valve Bicuspidia