Characterization and Outcomes of Patients Screened for Transcatheter Tricuspid Valve Replacement

Xijing Hospital340 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

340

Conditions

High-surgical Risk Patients with Severe Tricuspid Regurgitation

Interventions

transcatheter tricuspid valve replacementPROCEDURE

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atrial disc to ensure the elimination of TR, septal anchoring was performed, and the delivery system was subsequently withdrawn.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

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * (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. Exclusion Criteria: * (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.

Locations (8)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

Fuwai Hospital

Beijing, Beijing Municipality, China

Xiamen Cardiovascular Hospital

Xiamen, Fujian, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Outcomes

Primary Outcomes

screening failure rate

Time frame: baseline， postprocedural immediately，30 days postprocedurally，6 months postprocedurally，1 year postprocedurally

Data from ClinicalTrials.gov

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