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Completed

NCT Number: NCT04205474

Aortic Valve Dynamics During Exercise After Valve Sparing Root Replacement Surgery

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.

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Key information

Conditions

Aneurysm Aortic Root Aneurysm Aortic Aneurysm Aortic Aneurysm, Thoracic Aortic Diseases Aortic Root Aneurysm Aortic Valve Disease Aortic Valve, Bicuspid Bicuspid Aortic Valve Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Valve Diseases Vascular Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Cardiac Surgery, University Hospital

Ghent, België, 9000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

graded bicycle test

Diagnostic Test

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

Primary outcomes

  1. Echocardiographic gradients in mmHg and velocity across the aortic valve in m/sec at each exercise level

    Time frame: from 1 year postoperatively

    obtained 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

  2. comparison between peak gradients in mmHg across tricuspid and bicuspid aortic valves

    Time frame: from 1 year postoperatively

    obtained with transthoracic echocardiography during exercise, at each exercise level

Secondary outcomes

  1. comparison between gradients across aortic valve in unoperated and operated patients

    Time frame: 1 year

    gradients in mmHg across the aortic valve, measured by transthoracic echocardiography, at increasing afterload levels, on a reclining bicycle

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Dec 19, 2019
Registry last updated
Dec 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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