NCT03298932

Brief Summary

Evaluation of the right ventricle (RV) deformation (strain) with 2D speckle tracking technics obtained by echocardiographies (TEE) in peroperative period of cardiac surgery . TEE is performed for each patient of cardiac surgery during the operation time . This new evaluation parameter of RV could be a good tool to assess the early RV dysfunction after cardiac surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 19, 2016

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 2, 2017

Completed
Last Updated

March 29, 2018

Status Verified

October 1, 2016

Enrollment Period

3 months

First QC Date

October 11, 2016

Last Update Submit

March 27, 2018

Conditions

Aortic Valve Disorder

Keywords

Transesophageal echographyPerioperative cardiac surgeryAortic valve replacement2D strain of right ventricle

Outcome Measures

Primary Outcomes (1)

  • 2D strain modification of right ventricle after cardiac surgery

    up to 24 hours

Interventions

Aortic valve surgeryPROCEDURE

Aortic valve surgery

Eligibility Criteria

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

Patient eligible for aortic valve surgery

You may qualify if:

  • patient eligible for aortic valve surgery

You may not qualify if:

  • previous right ventricle dysfunction
  • severe coronary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Arnaud de Villeneuve réanimation

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Géraldine CULAS, MD

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 11, 2016

First Posted

October 2, 2017

Study Start

September 19, 2016

Primary Completion

January 1, 2017

Study Completion

June 7, 2017

Last Updated

March 29, 2018

Record last verified: 2016-10

Locations

FR(1)