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.

Study Overview

• Status: Completed
• Conditions: Aneurysm Aortic Root; Aortic Valve, Bicuspid
• Intervention / Treatment: Diagnostic test: graded bicycle test

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • België
    • Ghent, België, Belgium, 9000
      • Department of Cardiac Surgery, University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: VSRR with tricuspid aortic valve; Patients with a tricuspid valve that previously underwent a valve sparing root procedure for aortic root aneurysm	Diagnostic test: graded bicycle test; the subjects perform an exercise test on a reclining bicycle, and perform against increasing afterload
Active Comparator: VSRR with bicuspid aortic valve; Patients with a bicuspid valve that previously underwent a valve sparing root procedure for aortic root aneurysm	Diagnostic test: graded bicycle test; the subjects perform an exercise test on a reclining bicycle, and perform against increasing afterload

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Echocardiographic gradients in mmHg and velocity across the aortic valve in m/sec at each exercise level	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	from 1 year postoperatively
comparison between peak gradients in mmHg across tricuspid and bicuspid aortic valves	obtained with transthoracic echocardiography during exercise, at each exercise level	from 1 year postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
comparison between gradients across aortic valve in unoperated and operated patients	gradients in mmHg across the aortic valve, measured by transthoracic echocardiography, at increasing afterload levels, on a reclining bicycle	1 year

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Investigators: Principal Investigator: Katrien Francois, MD, PhD, University Hospital Ghent, Belgium

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2019
• Primary Completion (Actual): September 10, 2020
• Study Completion (Actual): January 1, 2021

Study Registration Dates

• First Submitted: December 15, 2019
• First Submitted That Met QC Criteria: December 17, 2019
• First Posted (Actual): December 19, 2019

Study Record Updates

• Last Update Posted (Actual): December 28, 2022
• Last Update Submitted That Met QC Criteria: December 23, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: valve sparing procedure; reimplantation
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Aortic Valve Disease; Heart Valve Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Aortic Diseases; Aneurysm; Bicuspid Aortic Valve Disease; Aortic Aneurysm
• Other Study ID Numbers: HCH_VSRR_1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No