Characterization and Outcomes of Patients Screened for Transcatheter Tricuspid Valve Replacement
The TRI-RECRUI
1 other identifier
observational
340
1 country
8
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2023
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedFirst Submitted
Initial submission to the registry
March 2, 2025
CompletedFirst Posted
Study publicly available on registry
March 6, 2025
CompletedMarch 6, 2025
March 1, 2025
1.3 years
March 2, 2025
March 2, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
screening failure rate
baseline， postprocedural immediately，30 days postprocedurally，6 months postprocedurally，1 year postprocedurally
Study Arms (1)
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
Interventions
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atrial disc to ensure the elimination of TR, septal anchoring was performed, and the delivery system was subsequently withdrawn.
Eligibility Criteria
340 consecutive patients for TTVR screening using LuX-Valve Plus at seven cardiac centers.
You may qualify if:
- (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.
You may not qualify if:
- (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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xijing Hospitallead
Study Sites (8)
Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100011, China
Fuwai Hospital
Beijing, Beijing Municipality, 100037, China
Xiamen Cardiovascular Hospital
Xiamen, Fujian, 361102, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430040, China
Department of Cardiovascular Surgery, Xijing Hospital
Xi'an, Shaanxi, 710032, China
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080, China
West China Hospital
Chengdu, Sichuan, 610041, China
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.
Study Record Dates
First Submitted
March 2, 2025
First Posted
March 6, 2025
Study Start
March 1, 2023
Primary Completion
June 30, 2024
Study Completion
June 30, 2024
Last Updated
March 6, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share