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

• Sponsor: Tufts Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05130775
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Anticipated Duration (Months): 10.7
• Patients Per Site Per Month: 5.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tricuspid Regurgitation	Other: Transesophageal echocardiograpgy

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 60 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Measurement of Tricuspid Regurgitation Volume for Assessment of Tricuspid Regurgitation Using 3D Transesophageal Echocardiography
• Anticipated Study Start Date: Aug 22, 2022
• Anticipated Primary Completion Date: Jul 15, 2023
• Anticipated Study Completion Date: Jul 15, 2023

Outcome Measures

Primary Outcome Measures

1. Tricuspid regurgitation volume [12 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tufts Medical Center	Boston	Massachusetts	United States	02111

Sponsors and Collaborators

• Tufts Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tufts Medical Center
• ClinicalTrials.gov Identifier: NCT05130775
• Other Study ID Numbers: 00001677
• First Posted: Nov 23, 2021
• Last Update Posted: Jul 12, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Tricuspid Valve Insufficiency

Study Results

No Results Posted as of Jul 12, 2022