Evaluation of New Items in Cardiac Echography | NCT03011073

Studies
Evaluation of New Items in Cardiac Echography

NCT03011073

Sponsor

Fondation Hôpital Saint-Joseph

Status

Withdrawn

Last Update Posted

Nov 8, 2017Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Cardiac Echography
Cardiac Ultrasound

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

investigator decision

Expanded Access Info

Start Date

Oct 1, 2017Actual

Primary Completion Date

Oct 1, 2017Actual

Completion Date

Oct 6, 2018Estimated

First Submitted Date

Jan 3, 2017

First Submission Date that Met QC Criteria

Jan 4, 2017

First Posted Date

Jan 5, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 7, 2017

Last Update Posted Date

Nov 8, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Paris Saint Joseph hospital has just acquired a new echocardiography EPIC . This new system has image processing and left ventricular function quantification software which are different from the precedent model Philips IE33.Left ventricular function quantification and myocardial distortion are the main medical examination influencing doctor's decisions.

EPIC can evaluate and quantify the cardiac ejection fraction via new software. Myocardial distortion quantification software also has been modified with new cut off and different calculation method.

The aim of this study is to compare the quality of images and the quantification of cardiac ejection fraction with these new software in order to choose the more reliable and reproducible for patient.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cardiac left ejection fraction	Evaluation of left ejection fraction by 3D	Day 1

Secondary Outcomes

Measure	Description	Time Frame
Echographic images evaluation		day 1

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patient accepting to stay 15 min more
Age > 18 years old

Exclusion Criteria:

patient not accepting this procedure

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patient who have prescription to do an cardiac ultrasound

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided