High-surgical Risk Patients with Severe Tricuspid RegurgitationThe TRI-RECRUINCT06862765
Characterization and Outcomes of Patients Screened for Transcatheter Tricuspid Valve Replacement
An observational study of High-surgical Risk Patients with Severe Tricuspid Regurgitation, run by Xijing Hospital at 8 sites in China.
Trial summary
The TRI-RECRUIT Study was conducted of 340 consecutive patients for TTVR screening using LuX-Valve via the trans-jugular vein approach at seven cardiac centers. Patient-level clinical records, imaging dates and screening outcomes were retrospectively collected. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High-surgical Risk Patients with Severe Tricuspid Regurgitation
- What is being tested?
- transcatheter tricuspid valve replacement
- Type of treatment
- Surgery or procedure
- How many people
- 340 participants
- Where
- 8 sitesChina
- Study dates
- 1 Mar 2023to 30 Jun 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: 340 consecutive patients for TTVR screening using LuX-Valve Plus at seven cardiac centers.
Who may be able to join
- (i) age > 18 years old; (ii) TR severity ≥ severe; (iii) New York Heart Association (NYHA) functional class ≥ Ⅱ; (iv) failed GDMT; (v) Euro-SCORE > 4.
Who cannot join
- (i) left ventricular ejection fraction < 40%; (ii) systolic pulmonary arterial pressure > 60 mmHg; (iii) prior TV surgery or left-sided valve surgery within the past 6 months; (iv) irreversible poor right ventricular function; (v) concomitant significant lesion needed for other major cardiac procedures or infective endocarditis.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100011
Fuwai Hospital
Beijing, Beijing Municipality, 100037
West China Hospital
Chengdu, Sichuan, 610041
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430040
Department of Cardiovascular Surgery, Xijing Hospital
Xi'an, Shaanxi, 710032
Xiamen Cardiovascular Hospital
Xiamen, Fujian, 361102
About this study
Official title: Characterization and Outcomes of Patients Screened for Transcatheter Tricuspid Valve Replacement with LuX-Valve Via the Trans-jugular Vein Approach
The TRI-RECRUIT Study was conducted of 340 consecutive patients for TTVR screening using LuX-Valve via the trans-jugular vein approach at seven cardiac centers. Patient-level clinical records, imaging dates and screening outcomes were retrospectively collected.
- Being tested
- transcatheter tricuspid valve replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcatheter tricuspid valve replacementProcedure or surgery
The LuX-valve was implanted under fluoroscopic and echocardiographic guidance via the transjugular vein approach. Once the delivery system was introduced, it was adjusted within the right heart chamber to be perpendicular to the tricuspid annulus. The anterior leaflet was grasped using two leaflet graspers, and the ventricular portion of the device component was gradually released. After deploying the atrial disc to ensure the elimination of TR, septal anchoring was performed, and the delivery system was subsequently withdrawn.
| Study group | Role | What they receive |
|---|---|---|
| TTVR Screening | In this study ,235 patients were screened successed for TTVR with LuX-Valve via the trans-jugular vein, and 105 patients were screend failed Receives: Procedure: transcatheter tricuspid valve replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
screening failure rate
Measured: baseline， postprocedural immediately，30 days postprocedurally，6 months postprocedurally，1 year postprocedurally
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start1 Mar 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-surgical Risk Patients with Severe Tricuspid 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Yang, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06862765
- Sponsor's protocol ID
- KY20192138
- Acronym
- The TRI-RECRUI
- Status last verified
- Mar 2025
- First submitted
- 2 Mar 2025
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization and Outcomes of Patients Screened for Transcatheter Tricuspid Valve Replacement with LuX-Valve Via the Trans-jugular Vein Approach
- ClinicalTrials.gov ID
- NCT06862765
- Acronym / sponsor ID
- The TRI-RECRUI / KY20192138
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 6 Mar 2025 (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.
The TRI-RECRUIT Study was conducted of 340 consecutive patients for TTVR screening using LuX-Valve via the trans-jugular vein approach at seven cardiac centers. Patient-level clinical records, imaging dates and screening outcomes were retrospectively collected.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TTVR Screening | – | Procedure: transcatheter tricuspid valve replacementIn this study ,235 patients were screened successed for TTVR with LuX-Valve via the trans-jugular vein, and 105 patients were screend failed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 340 consecutive patients for TTVR screening using LuX-Valve Plus at seven cardiac centers.
Key inclusion criteria (1 listed)
- (i) age > 18 years old; (ii) TR severity ≥ severe; (iii) New York Heart Association (NYHA) functional class ≥ Ⅱ; (iv) failed GDMT; (v) Euro-SCORE > 4.
Key exclusion criteria (1 listed)
- (i) left ventricular ejection fraction < 40%; (ii) systolic pulmonary arterial pressure > 60 mmHg; (iii) prior TV surgery or left-sided valve surgery within the past 6 months; (iv) irreversible poor right ventricular function; (v) concomitant significant lesion needed for other major cardiac procedures or infective endocarditis.
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 |
|---|---|---|
| transcatheter tricuspid valve replacementThe LuX-valve was implanted under fluoroscopic and echocardiographic guidance via the transjugular vein approach. Once the delivery system was introduced, it was adjusted within the right heart chamber to be perpendicular to the tricuspid annulus. The anterior leaflet was grasped using two leaflet graspers, and the ventricular portion of the device component was gradually released. After deploying the atrial disc to ensure the elimination of TR, septal anchoring was performed, and the delivery system was subsequently withdrawn. | Procedure or surgery | TTVR Screening |
Primary outcome
screening failure rate
Time frame: baseline， postprocedural immediately，30 days postprocedurally，6 months postprocedurally，1 year postprocedurally
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 6 Mar 2025.
- Individual participant dataSharing planned: No
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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High-surgical Risk Patients with Severe Tricuspid Regurgitation, run by Xijing Hospital at 8 sites 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 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: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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.
What does the primary outcome measure?
screening failure rate (time frame: baseline， postprocedural immediately，30 days postprocedurally，6 months postprocedurally，1 year postprocedurally). 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 6 Mar 2025.