Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)

Innoventric

Status

Enrolling

Conditions

Tricuspid Regurgitation Functional

Tricuspid Regurgitation

Treatments

Device: Trillium™

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT06212193

CLD-048

Details and patient eligibility

About

Early Feasibility Study to evaluate the safety and performance of the Innoventric Trillium™ Stent Graft in the treatment of severe or greater tricuspid regurgitation (TR).

Full description

Prospective, single arm, multi-center, Early Feasibility Study (EFS) to assess the safety and performance of the Innoventric Trillium™ Stent Graft in the treatment of severe or greater tricuspid regurgitation (TR).

Up to fifteen (15) patients at up to 10 US investigational sites and 3 German investigational sites will be enrolled. All enrolled study patients will be assessed at baseline, during the procedure, at discharge, and after 1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years following the index procedure.

Enrollment

15 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient has clinically significant TR graded as severe or greater
Peak central venous pressure of ≥ 15mmHg
Patient has NYHA functional classification of III or IV
Patient is not eligible for standard-of-care surgical or interventional therapy or has refused standard-of-care surgical and interventional therapy or has received standard-of-care TR therapy and remains symptomatic

Exclusion criteria

Patients will be excluded from participation if ANY of the following criteria apply:

Severe RV dysfunction defined by TAPSE, RVEF, or RVFAC.
Anatomical suitability according to CT scan.
Systolic Pulmonary Artery Pressure > 65mmHg
Moderate or more mitral valve stenosis
Greater than moderate mitral valve regurgitation or aortic valve stenosis/regurgitation
Moderate mitral valve regurgitation combined with moderate aortic valve stenosis/regurgitation
Kidney dysfunction with estimated Glomerular Filtration Rate (eGFR) < 35 ml/min/1.73 m2 within 60 days prior to the index procedure or patient is on chronic dialysis
Liver cirrhosis or moderate or severe liver disease (Child-Turcotte-Pugh class B or C, or a score of 7 or higher)
Thrombocytopenia (Platelet count< 80,000/mm3) or thrombocytosis (Platelet count > 750,000/mm3) within 14 days of the index procedure
In the opinion of the Investigator or the study eligibility committee, the patient's life expectancy < 12 months