Measurement of Tricuspid Regurgitation Volume for Assessm... | NCT05130775

Studies
Measurement of Tricuspid Regurgitation Volume for Assessment of Tricuspid Regurgitation Using 3D Transesophageal Echocardiography

NCT05130775

Sponsor

Tufts Medical Center

Status

Withdrawn

Last Update Posted

Jan 5, 2024Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Tricuspid Regurgitation

Interventions

Transesophageal echocardiograpgy

Countries

United States

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

Jan 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study was stopped due to non availability of sample for data collection

Expanded Access Info

Start Date

Aug 5, 2022Actual

Primary Completion Date

Aug 5, 2022Actual

Completion Date

Aug 5, 2022Actual

First Submitted Date

Nov 15, 2021

First Submission Date that Met QC Criteria

Nov 15, 2021

First Posted Date

Nov 23, 2021Actual

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

Jan 3, 2024

Last Update Posted Date

Jan 5, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

This study is a prospective observational chart review. The aim of the study is to evaluate tricuspid regurgitation volume using 3D volumetric assessment as an accurate method for tricuspid regurgitation severity in comparison to VCA.

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

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transesophageal echocardiograpgy	Other	3D acquisition of the right ventricle regurgitation volume

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Tricuspid regurgitation volume	We will evaluate patients with different grades TR by both 3DVCA and the 3D volumetric approach	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

-All degrees of tricuspid regurgitation minimal, mild, moderate and severe will be included

Exclusion Criteria:

Exclusion criteria will be non-sinus rhythm, more than mild pulmonary regurgitation, more than trace aortic regurgitation.

Accepts Healthy Volunteers

Not provided

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

18 years and older with all grades of tricuspid regurgitation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tufts Medical Center		Boston	Massachusetts	02111	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014262	Tricuspid Valve Insufficiency

Ancestor Terms

ID	Term
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided