NCT05130775

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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
withdrawn

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

November 15, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 23, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

August 5, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2022

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

Same day

First QC Date

November 15, 2021

Last Update Submit

January 3, 2024

Conditions

Tricuspid Regurgitation

Outcome Measures

Primary Outcomes (1)

  • Tricuspid regurgitation volume

    We will evaluate patients with different grades TR by both 3DVCA and the 3D volumetric approach

    12 months

Interventions

Transesophageal echocardiograpgyOTHER

3D acquisition of the right ventricle regurgitation volume

Eligibility Criteria

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

18 years and older with all grades of tricuspid regurgitation

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2021

First Posted

November 23, 2021

Study Start

August 5, 2022

Primary Completion

August 5, 2022

Study Completion

August 5, 2022

Last Updated

January 5, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

Locations

US(1)