Tricuspid Valve Regurgitation; Complications, Longterm OutcomeNCT06554119
Surgical Treatments of Tricuspid Valve Regurgitation After Cardiac Surgery
An observational study of Tricuspid Valve Regurgitation; Complications, Longterm Outcome, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
This study aims to present our center's experience in managing postoperative tricuspid valve regurgitation over the past 25years and to analyze the outcomes of these surgical treatments. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Tricuspid Valve Regurgitation; Complications, Longterm Outcome
- What is being tested?
- Huanlei Huang
- Type of treatment
- Surgery or procedure
- How many people
- 375 participants
- Where
- 1 siteChina
- Study dates
- Jan 1999to Jan 2025
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients who underwent surgical treatment from 1999 to 2023 for tricuspid valve disease following cardiac surgery
Inclusion Criteria:patients who underwent surgical treatment from 1999 to 2023 for tricuspid valve disease following cardiac surgery
Exclusion Criteria: age <16，severe tricuspid regurgitation secondary to primary pulmonary hypertension, and those with substantial missing case data.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University
Guangzhou, Guangdong, 510080
Huanlei Huang, 02083827812, hhuanlei@hotmail.com
Yingjie Ke
About this study
Official title: Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University
This study aims to present our center's experience in managing postoperative tricuspid valve regurgitation over the past 25years and to analyze the outcomes of these surgical treatments.
- Being tested
- Huanlei Huang
- Keywords
- tricuspid valve regurgitation; technique advances; complications
- 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.
Huanlei HuangProcedure or surgery
tricuspid valve replacement or plasty
| Study group | Role | What they receive |
|---|---|---|
| TVR | tricuspid valve replacement group， Receives: Procedure: Huanlei Huang | |
| TVP | tricuspid valvuloplasty group Receives: Procedure: Huanlei Huang |
What is being measured
The primary outcome is the main question the study is designed to answer.
death rate
perioperative and longterm
Measured: 1999-01 - 2025-01
complications
perioperative and longterm complications
Measured: 1999-01 - 2025-01
Secondary outcomes (1)
redo of tricuspid valve
redo of tricuspid valve during the follow-up
Measured: 1999-01 - 2025-01
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study startJan 1999
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid Valve Regurgitation; Complications, Longterm OutcomeStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 375 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huanlei Huang, PhD, Guangdong Provincial People's Hospital
- Investigators
- Huanlei Huang, Study director, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06554119
- Sponsor's protocol ID
- Guangdong Provincial PHosp
- Status last verified
- Aug 2024
- First submitted
- 13 Aug 2024
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University
- ClinicalTrials.gov ID
- NCT06554119
- Acronym / sponsor ID
- Guangdong Provincial PHosp
- Keywords
- tricuspid valve regurgitation; technique advances; complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 375 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- Jan 1999 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 15 Aug 2024 (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 aims to present our center's experience in managing postoperative tricuspid valve regurgitation over the past 25years and to analyze the outcomes of these surgical treatments.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TVR | – | Procedure: Huanlei Huangtricuspid valve replacement group， |
| TVP | – | Procedure: Huanlei Huangtricuspid valvuloplasty group |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients who underwent surgical treatment from 1999 to 2023 for tricuspid valve disease following cardiac surgery
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 |
|---|---|---|
| Huanlei Huangtricuspid valve replacement or plasty | Procedure or surgery | TVP, TVR |
Primary outcome
death rate
Time frame: 1999-01 - 2025-01
perioperative and longterm
complications
Time frame: 1999-01 - 2025-01
perioperative and longterm complications
1 secondary outcome
redo of tricuspid valve
Time frame: 1999-01 - 2025-01
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Individual participant dataSharing planned: Undecided
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.
Huanlei Huang study director
Guangdong Provincial People's 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; Complications, Longterm Outcome, run by Guangdong Provincial People's 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?
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: status not confirmed, as of the sponsor's last update on 15 Aug 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huanlei Huang (02083827812-10410, hhuanlei@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
death rate (time frame: 1999-01 - 2025-01). The study lists 2 primary outcomes in all. 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 15 Aug 2024.