NCT03628313

Brief Summary

Aortic stenosis is the most common valvulopathy in Western countries. Cardiac EchoDoppler is the reference method for assessment of aortic stenosis and provides prognostic elements. However, it is imperfect with many inconsistencies between measures. On the other hand, the prognosis of patients with low flow and low gradient aortic retraction is discussed. The main objective of this work is to study the prognosis of asymptomatic and symptomatic aortic retraction.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 14, 2018

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

February 10, 2023

Status Verified

February 1, 2023

Enrollment Period

9.8 years

First QC Date

July 31, 2018

Last Update Submit

February 9, 2023

Conditions

Morality

Keywords

EchoacrdiographyEchoDopplerAortic valve stenosisPrognosis

Outcome Measures

Primary Outcomes (1)

  • Prognosis of asymptomatic and symptomatic aortic valve stenosis

    Aortic valve stenosis (Rao) is the most common valvulopathy in Western countries. Cardiac EchoDoppler represents the reference method of evaluation of Rao and provides prognostic elements. However, it is imperfect with many inconsistencies between measures. On the other hand, the prognosis of patients with low-gradient and low-gradient Rao is discussed.) The main objective of this work is to study the prognosis of asymptomatic and symptomatic aortic valve stenosis. To Look for predictors of prognosis and To Evaluate the impact of comorbidities on the prognosis of RAo Evaluate operative indications and specify the short and long term outcome after surgery.

    6 years

Study Arms (1)

Aortic valve stenosis

The participants will be identified from the Transthoracic ultrasound echocardiography reports of the echocardiography laboratory of the University Hospital of Amiens and CH Philibert for the retrospective part. They are analyzed during echocardiography at the echocardiography laboratory of two participating centers when a diagnosis of aortic stenosis is made. Patients are informed by newsletter.

Other: Transthoracic ultrasound

Interventions

Transthoracic ultrasoundOTHER

Patients are prospectively identified during echocardiography performed in the echocardiography laboratory of the two participating centers when a diagnosis of aortic stenosis is made.

Aortic valve stenosis

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The participants will be identified from the transthoracic echocardiography reports of the echocardiography laboratory of CHU Amiens and CH Saint Philibert for the retrospective part. They are prospectively identified during echocardiography performed in the echocardiography laboratory of the two participating centers when a diagnosis of aortic stenosis is made. Patients will be informed by newsletter.

You may qualify if:

  • Retrospectively, all patients examined from January 1, 2000 to November 2014 will be included in the echocardiography laboratory whose objective examination is a narrowing of the aortic valve (maximum transaortic velocity ≥2.5 m / s).
  • Aortic stenosis may be known in the past.

You may not qualify if:

  • Refusal of the patient to participate in the study.
  • Patients who have previously had aortic valve surgery before being examined in the echocardiography laboratory.
  • Patients who can not be contacted or who do not respond will not be included in the database.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Amiens-Picardie

Amiens, 80000, France

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Christophe TRIBOUILLOY, MD, PhD

    CHU AMIENS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christophe TRIBOUILLOY, MD, PhD

CONTACT

0322087251Tribouilloy.Christophe@chu-amiens.fr

Sylvestre MARECHAUX, MD, PhD

CONTACT

0320225050sylvestre.marechaux@yahoo.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2018

First Posted

August 14, 2018

Study Start

September 1, 2015

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

February 10, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)