Clinical trial NCT04205474: Aortic Valve Dynamics During Exercise After Valve Sparing Root Replacement Surgery
Official title: Aortic Valve Dynamics During Exercise After Valve Sparing Root Replacement Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aneurysm Aortic Root
Aortic Valve, Bicuspid
Keywords: valve sparing procedure
reimplantation
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2019-12-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Echocardiographic gradients in mmHg and velocity across the aortic valve in m/sec at each exercise level
timeFrame: from 1 year postoperatively
measure: comparison between peak gradients in mmHg across tricuspid and bicuspid aortic valves
timeFrame: from 1 year postoperatively
Secondary outcomes:
measure: comparison between gradients across aortic valve in unoperated and operated patients
timeFrame: 1 year
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Department of Cardiac Surgery, University Hospital
state: België
Study officials:
affiliation: University Hospital Ghent, Belgium
name: Katrien Francois, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: