NCT03183414

Brief Summary

To establish the correlation between echocardiographic parameters of the RV, measured with TEE and the right ventricular ejection fraction (thermodilution). To identify a time in the perioperative process when RV dysfunction occurs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2017

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

First Submitted

Initial submission to the registry

June 8, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 12, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

September 6, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2018

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

November 26, 2019

Status Verified

November 1, 2019

Enrollment Period

10 months

First QC Date

June 8, 2017

Last Update Submit

November 25, 2019

Conditions

Keywords

cardiac surgerytransoesophageal echocardiography

Outcome Measures

Primary Outcomes (1)

  • The correlation between echocardiographic parameters of the RV, measured with TEE and the RVEF measured with the pulmonary artery catheter

    The correlation between echocardiographic parameters of the RV, measured with TEE and the RVEF measured with the pulmonary artery catheter.

    during cardiac surgery

Study Arms (1)

cardiac surgery patients

cardiac surgery patients with a significant peroperative aortic valve stenosis (gradient\>40mmHg and/or aortic valve area \<1cm2). During cardiac surgery measurements of right ventricular dysfunction were taken by echocardiography

Other: echocardiographic measurements

Interventions

echocardiographic parameters of the RV, measured with TEE and the right ventricular ejection fraction (thermodilution)

cardiac surgery patients

Eligibility Criteria

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

15 cardiac surgery patients (elective, isolated aortic valve replacement or coronary artery bypass grafting in combination with aortic valve replacement) with a significant preoperative aortic valve stenosis (gradient\>40mmHg and/or aortic valve area \<1cm2)

You may qualify if:

  • cardiac surgery patients
  • elective, isolated aortic valve replacement or coronary artery bypass grafting in combination with aortic valve replacement

You may not qualify if:

  • age \< 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Centre Leeuwarden

Leeuwarden, 8934AD, Netherlands

Location

MeSH Terms

Conditions

Ventricular Dysfunction, Right

Condition Hierarchy (Ancestors)

Ventricular DysfunctionHeart DiseasesCardiovascular Diseases

Study Officials

  • Christiaan Boerma, MD

    MCL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

June 8, 2017

First Posted

June 12, 2017

Study Start

September 6, 2017

Primary Completion

June 20, 2018

Study Completion

June 30, 2018

Last Updated

November 26, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

not available, patient data is anonym

Locations