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Characterization and Outcomes of Patients Screened for Transcatheter Tricuspid Valve Replacement (The TRI-RECRUI)

A

Air Force Military Medical University of People's Liberation Army

Status

Completed

Conditions

High-surgical Risk Patients with Severe Tricuspid Regurgitation

Treatments

Procedure: transcatheter tricuspid valve replacement

Study type

Observational

Funder types

Other

Identifiers

NCT06862765
KY20192138

Details and patient eligibility

About

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.

Enrollment

340 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

340 participants in 1 patient group

TTVR Screening
Description:
In this study ,235 patients were screened successed for TTVR with LuX-Valve via the trans-jugular vein, and 105 patients were screend failed
Treatment:
Procedure: transcatheter tricuspid valve replacement

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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