Aortic Valve Dynamics During Exercise After Valve Sparing Root Replacement Surgery

NCT04205474 | Completed

• 1 other identifier: HCH_VSRR_1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Aneurysm Aortic Root; Aortic Valve, Bicuspid

Keywords

valve sparing procedure; reimplantation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• comparison between gradients across aortic valve in unoperated and operated patients

  1 year

Study Arms (2)

VSRR with tricuspid aortic valve

ACTIVE COMPARATOR

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

Diagnostic Test: graded bicycle test

VSRR with bicuspid aortic valve

ACTIVE COMPARATOR

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

Diagnostic Test: graded bicycle test

Interventions

graded bicycle test DIAGNOSTIC_TEST

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

VSRR with bicuspid aortic valve; VSRR with tricuspid aortic valve

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \<18 years or \>60 years of age
• peak gradient across the aortic valve at rest of \>20mmHg
• decreased left ventricular function

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Department of Cardiac Surgery, University Hospital

Ghent, België, 9000, Belgium

Location

MeSH Terms

Conditions

Aortic Root Aneurysm; Bicuspid Aortic Valve Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Katrien Francois, MD, PhD

  University Hospital Ghent, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2019
• First Posted: December 19, 2019
• Study Start: December 16, 2019
• Primary Completion: September 10, 2020
• Study Completion: January 1, 2021
• Last Updated: December 28, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)