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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05130775
Other study ID # 00001677
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date August 5, 2022
Est. completion date August 5, 2022

Study information

Verified date January 2024
Source Tufts Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date August 5, 2022
Est. primary completion date August 5, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Transesophageal echocardiograpgy
3D acquisition of the right ventricle regurgitation volume

Locations

Country Name City State
United States Tufts Medical Center Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Tufts Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tricuspid regurgitation volume We will evaluate patients with different grades TR by both 3DVCA and the 3D volumetric approach 12 months
See also
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Active, not recruiting NCT02675244 - Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery N/A
Recruiting NCT05436028 - A Study to Evaluate the Safety and Performance of LuX-Valve Plus System for Tricuspid Replacement N/A