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Aortic Valve Dynamics During Exercise After Valve Sparing Root Replacement Surgery

Primary Purpose

Aneurysm Aortic Root, Aortic Valve, Bicuspid

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
graded bicycle test
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Aneurysm Aortic Root focused on measuring valve sparing procedure, reimplantation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Cardiac Surgery, University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

VSRR with tricuspid aortic valve

VSRR with bicuspid aortic valve

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
comparison between peak gradients in mmHg across tricuspid and bicuspid aortic valves
obtained with transthoracic echocardiography during exercise, at each exercise level

Secondary Outcome Measures

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

Full Information

First Posted
December 15, 2019
Last Updated
December 23, 2022
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT04205474
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
December 16, 2019 (Actual)
Primary Completion Date
September 10, 2020 (Actual)
Study Completion Date
January 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aneurysm Aortic Root, Aortic Valve, Bicuspid
Keywords
valve sparing procedure, reimplantation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VSRR with tricuspid aortic valve
Arm Type
Active Comparator
Arm Description
Patients with a tricuspid valve that previously underwent a valve sparing root procedure for aortic root aneurysm
Arm Title
VSRR with bicuspid aortic valve
Arm Type
Active Comparator
Arm Description
Patients with a bicuspid valve that previously underwent a valve sparing root procedure for aortic root aneurysm
Intervention Type
Diagnostic Test
Intervention Name(s)
graded bicycle test
Intervention Description
the subjects perform an exercise test on a reclining bicycle, and perform against increasing afterload
Primary Outcome Measure Information:
Title
Echocardiographic gradients in mmHg and velocity across the aortic valve in m/sec at each exercise level
Description
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
Time Frame
from 1 year postoperatively
Title
comparison between peak gradients in mmHg across tricuspid and bicuspid aortic valves
Description
obtained with transthoracic echocardiography during exercise, at each exercise level
Time Frame
from 1 year postoperatively
Secondary Outcome Measure Information:
Title
comparison between gradients across aortic valve in unoperated and operated patients
Description
gradients in mmHg across the aortic valve, measured by transthoracic echocardiography, at increasing afterload levels, on a reclining bicycle
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katrien Francois, MD, PhD
Organizational Affiliation
University Hospital Ghent, Belgium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiac Surgery, University Hospital
City
Ghent
State/Province
België
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

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Aortic Valve Dynamics During Exercise After Valve Sparing Root Replacement Surgery

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