A Study to Evaluate the Safety and Performance of LuX-Valve Plus System for Tricuspid Replacement

J

Jenscare Scientific

Status

Enrolling

Conditions

Tricuspid Regurgitation

Treatments

Device: Transcatheter Tricuspid Valve Intervention

Study type

Interventional

Funder types

Industry

Identifiers

NCT05436028
JSNL-CIP-TVS02-01CE

Details and patient eligibility

About

This is a prospective, single-arm, multi-center trial to evaluate the LuX-Valve Plus system for treating symptomatic severe or greater TR in patients who are deemed high risk for tricuspid surgery. Treatment with the LuX-Valve Plus system may enable patients with tricuspid regurgitation to have a complete tricuspid valve replacement with a minimally invasive approach. A total of 93 subjects will be enrolled at up to 20 institutions worldwide. No single institution will be allowed to register more than 25% of total subjects. There is no minimum number of subjects to be registered at any site. Up to an additional 42 roll-in subjects, up to 3 per site, may be enrolled by operators without prior experience with the LuX-Valve Plus system to gain hands-on experience. The data of roll-in subjects will not count towards the overall enrollment cap. Safety and effectiveness results of roll-in subjects will be reported separately. All subjects will be evaluated at baseline, discharge, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years post-procedure

Enrollment

135 estimated patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age≥50 years at time of consent
  • Severe or greater TR (≥3+) assessed on transthoracic echocardiography by Echo Core Lab (ECL) using a 5-grade classification
  • New York Heart Association (NYHA) Class III or IV
  • In the judgment of the Site Heart Team, the subject has been adequately treated per applicable standards, including optimal medical therapy with diuretics
  • The Site Heart Team determined that the subject is appropriate for transcatheter tricuspid valve replacement, and the subject is at high risk for tricuspid valve surgery
  • Subject must provide written informed consent prior to any trial related procedure

Exclusion criteria

  • Systolic pulmonary artery pressure (sPAP) > 60 mmHg assessed by echocardiography
  • Left Ventricular Ejection Fraction (LVEF) <40%
  • Evidence of intracardiac mass, thrombus or vegetation
  • Anatomical structures precluding proper device deployment or device vascular access, evaluated by echo or CT
  • Ebstein Anomaly or congenital right ventricular dysplasia
  • Surgical correction is indicated for other concomitant valvular disease (e.g., severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation) Subjects with concomitant valvular disease may treat their respective valve first, and wait 2 months before being reassessed for the trial.
  • Pre-existing prosthetic valve(s) with clinically significant prosthetic dysfunction
  • Sepsis or active endocarditis within 3 months, or infections requiring antibiotic therapy within 2 weeks prior to the planned procedure
  • Untreated clinically significant coronary artery disease requiring revascularization
  • Acute myocardial infarction or unstable ischemia-related angina within prior 30 days
  • Any percutaneous coronary, intracardiac or carotid intervention within 30 days
  • Cerebrovascular stroke (ischemic or bleeding) within prior 3 months to enrollment
  • Active peptic ulcer or active gastrointestinal (GI) bleeding within prior 3 months to enrollment
  • Inability to tolerate anticoagulation or antiplatelet therapy
  • Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support
  • Renal insufficiency (eGFR < 30 ml/min per the Cockcroft-Gault formula) and/or renal replacement therapy at the time of screening
  • Chronic liver failure or cirrhosis with MELD-Albumin Score ≥ 12
  • Severe lung disease or patient dependent on home oxygen and deemed unsuitable by the local heart team or eligibility committee for the study.
  • Futility with estimated life expectancy<12 months.
  • Subjects currently participating in another clinical trial of an investigational drug or device that has not yet completed its primary endpoint.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

135 participants in 1 patient group

LuX-Valve Plus transvenous tricuspid valve and delivery system(LuX-Valve Plus System)
Experimental group
Description:
The LuX-Valve Plus System is intended for the treatment of patients with severe TR who are determined by a Heart Team to be at high risk of traditional open-heart surgery.
Treatment:
Device: Transcatheter Tricuspid Valve Intervention

Trial contacts and locations

1

Loading...

Central trial contact

Xing Li; Lei Xia

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems