Tricuspid Valve RegurgitationNCT01246141
The Comparison of Tricuspid Replacement and Repair in Patients With Combined Heart Valve Disease
An observational study of Tricuspid Valve Regurgitation, run by Xijing Hospital at 1 site in China.
Trial summary
Functional tricuspid regurgitation is common in patients with heart valve disease, replacement and repair both can correct this anomaly. However, there is no data to address which one can bring more benefits to these patients with combined heart valve disease. Read more about this study
- Who is it for?
- Ages 21 to 67 years
- Conditions the study is for
- Tricuspid Valve Regurgitation
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- Jan 1998to Apr 2010
- 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 21 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with aortic valve and mitral valve diseases and functional tricuspid valve regurgitation underwent surgical operations from Nov., 1998 to Dec., 2009 in our institute.
Who may be able to join
- Significant disorders in aortic and mitral valves
- Moderate ～ severe tricuspid regurgitation
- Underwent tricuspid repair or replacement operation
Who cannot join
- Isolate tricuspid valve lesion
- Mild tricuspid valve regurgitation
- Tricuspid valve regurgitation was left without surgical treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Institute of Cardiovascular Surgery
Functional tricuspid regurgitation is common in patients with heart valve disease, replacement and repair both can correct this anomaly. However, there is no data to address which one can bring more benefits to these patients with combined heart valve disease. The investigators retrospectively review patients with two or more heart valve disease and functional tricuspid regurgitation, and assess its long term outcomes.
Read the detailed description
we reviewed patients who admitted to our hospital due to combined heart valve disease, and underwent tricuspid valve replacement or repair from January,1998 to december,2009. we made a comparison between these two groups, in term of early results after operation and long term results.
- Conditions
- Tricuspid Valve Regurgitation
- Keywords
- tricuspid valve regurgitation, replacement, repair, outcomes
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Repair group | patients in repair group underwent tricuspid repair for functional tricuspid regurgitation. | |
| replacement group | In this group, patients underwent tricuspid valve replacement for functional tricuspid regurgitation. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2010 (estimated)
- Study startJan 1998
- Primary completionDec 2009
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid Valve RegurgitationStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Investigators
- zhang jinzhou, MD, Principal investigator, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01246141
- Sponsor's protocol ID
- 20101012
- Status last verified
- Jan 1998
- First submitted
- 20 Nov 2010
- Last updated
- 23 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Institute of Cardiovascular Surgery
- ClinicalTrials.gov ID
- NCT01246141
- Acronym / sponsor ID
- 20101012
- Conditions
- Tricuspid Valve Regurgitation
- Keywords
- tricuspid valve regurgitation, replacement, repair, outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Jan 1998
- Primary completion
- Dec 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 23 Nov 2010 (estimated)
- 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.
Functional tricuspid regurgitation is common in patients with heart valve disease, replacement and repair both can correct this anomaly. However, there is no data to address which one can bring more benefits to these patients with combined heart valve disease. The investigators retrospectively review patients with two or more heart valve disease and functional tricuspid regurgitation, and assess its long term outcomes.
Detailed description
we reviewed patients who admitted to our hospital due to combined heart valve disease, and underwent tricuspid valve replacement or repair from January,1998 to december,2009. we made a comparison between these two groups, in term of early results after operation and long term results.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Repair group | – | –patients in repair group underwent tricuspid repair for functional tricuspid regurgitation. |
| replacement group | – | –In this group, patients underwent tricuspid valve replacement for functional tricuspid regurgitation. |
Who may qualify
- Ages
- 21 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with aortic valve and mitral valve diseases and functional tricuspid valve regurgitation underwent surgical operations from Nov., 1998 to Dec., 2009 in our institute.
Key inclusion criteria (3 listed)
- Significant disorders in aortic and mitral valves
- Moderate ～ severe tricuspid regurgitation
- Underwent tricuspid repair or replacement operation
Key exclusion criteria (3 listed)
- Isolate tricuspid valve lesion
- Mild tricuspid valve regurgitation
- Tricuspid valve regurgitation was left without surgical treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2010.
Related trials for Tricuspid Valve Regurgitation
RecruitingObservational study
A Post-Market Assessment of the Safety and Performance of the TriClip™ System
Tricuspid Regurgitation (TR)
Not yet recruiting
TRI-SUCCESS - Tricuspid Regurgitation Study of the Unica™ Cross-Caval System for the Evaluation of Efficacy and Safety in Significant TR Subjects
Tricuspid Regurgitation, Tricuspid Regurgitation Functional
Recruiting
Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)
Tricuspid Regurgitation, Tricuspid Regurgitation Functional
Not yet recruitingObservational study
Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation
Aortic Stenosis, Mitral Regurgitation
Recruiting
Tricuspid Regurgitation Treatment With LAPLACE Transcatheter Tricuspid Valve Replacement System
Severe Tricuspid Valve Regurgitation, Tricuspid Valve Regurgitation
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.
zhang jinzhou, MD principal investigator
Xijing Hospital
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 Valve Regurgitation, run by Xijing Hospital at 1 site in China.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 23 Nov 2010. 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 China. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 23 Nov 2010.