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Aortic Valve Dynamics During Exercise After Valve Sparing Root Replacement Surgery

NCT ID: NCT04205474

Last Updated: 2022-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-16

Study Completion Date

2021-01-01

Brief Summary

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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

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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.

Conditions

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Aneurysm Aortic Root Aortic Valve, Bicuspid

Keywords

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valve sparing procedure reimplantation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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VSRR with tricuspid aortic valve

Patients with a tricuspid valve that previously underwent a valve sparing root procedure for aortic root aneurysm

Group Type ACTIVE_COMPARATOR

graded bicycle test

Intervention Type DIAGNOSTIC_TEST

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

VSRR with bicuspid aortic valve

Patients with a bicuspid valve that previously underwent a valve sparing root procedure for aortic root aneurysm

Group Type ACTIVE_COMPARATOR

graded bicycle test

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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graded bicycle test

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Katrien Francois, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Ghent, Belgium

Locations

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Department of Cardiac Surgery, University Hospital

Ghent, België, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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HCH_VSRR_1

Identifier Type: -

Identifier Source: org_study_id