Tricuspid RegurgitationNCT05130775
Measurement of Tricuspid Regurgitation Volume for Assessment of Tricuspid Regurgitation Using 3D Transesophageal Echocardiography
An observational study of Tricuspid Regurgitation, run by Tufts Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Regurgitation
- What is being tested?
- Transesophageal echocardiograpgy
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2022to 5 Aug 2022
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: 18 years and older with all grades of tricuspid regurgitation
Who may be able to join
- -All degrees of tricuspid regurgitation minimal, mild, moderate and severe will be included
Who cannot join
- Exclusion criteria will be non-sinus rhythm, more than mild pulmonary regurgitation, more than trace aortic regurgitation.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Tricuspid Regurgitation
- Being tested
- Transesophageal echocardiograpgy
- Medical subject headings
- Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transesophageal echocardiograpgyOther
3D acquisition of the right ventricle regurgitation volume
What is being measured
The primary outcome is the main question the study is designed to answer.
Tricuspid regurgitation volume
We will evaluate patients with different grades TR by both 3DVCA and the 3D volumetric approach
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start5 Aug 2022
- Primary completion5 Aug 2022
- Study completion5 Aug 2022
Why it stopped: The study was stopped due to non availability of sample for data collection
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05130775
- Sponsor's protocol ID
- 00001677
- Status last verified
- Jan 2024
- First submitted
- 15 Nov 2021
- Last updated
- 5 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Tricuspid Regurgitation Volume for Assessment of Tricuspid Regurgitation Using 3D Transesophageal Echocardiography
- ClinicalTrials.gov ID
- NCT05130775
- Acronym / sponsor ID
- 00001677
- Conditions
- Tricuspid Regurgitation
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study was stopped due to non availability of sample for data collection
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Study start
- 5 Aug 2022 (actual)
- Primary completion
- 5 Aug 2022 (actual)
- Study completion
- 5 Aug 2022 (actual)
- First posted
- 23 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 18 years and older with all grades of tricuspid regurgitation
Key inclusion criteria (1 listed)
- -All degrees of tricuspid regurgitation minimal, mild, moderate and severe will be included
Key exclusion criteria (1 listed)
- Exclusion criteria will be non-sinus rhythm, more than mild pulmonary regurgitation, more than trace aortic regurgitation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transesophageal echocardiograpgy3D acquisition of the right ventricle regurgitation volume | Other | – |
Primary outcome
Tricuspid regurgitation volume
Time frame: 12 months
We will evaluate patients with different grades TR by both 3DVCA and the 3D volumetric approach
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tricuspid Regurgitation, run by Tufts Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tricuspid regurgitation volume (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.