Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)

Official title

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)

Overview

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).

Detailed 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.

Interventions

• Device Trillium™
  Trillium™ Stent Graft for Cross-Caval Tricuspid Valve Replacement

Primary outcome measures

• Rate of Major Adverse Events [Safety endpoint] [Time frame: at the end of the procedure, at discharge - typically within a week, and 30 days]
• Technical Performance [Time frame: at the end of the procedure, at discharge - typically within a week, and 30 days]

Secondary outcome measures (2)

• Rate of Major Adverse Events [Safety endpoint] [Time frame: at 3 months, 6 months, 1, 2, 3, 4, and 5 years]
• Efficacy endpoint [Time frame: at 30 days, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year, and 5-year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 9 centers

• Cardiovascular Institute of Los Robles Health System — Thousand Oaks
• Ascension St. John — Detroit
• Mayo Clinic Hospital (Rochester) — Rochester
• Weill Cornell Medicine — New York
• Stony Brook Heart Institute — Stony Brook
• The Christ Hospital — Cincinnati
• Lankenau Heart Institute — Philadelphia
• TriStar Centennial Medical Center — Nashville
• … and 1 more center

Germany · 3 centers

• University Medicine Mainz — Mainz
• Helios Health Institute GmbH, Leipzig — Leipzig
• German Heart Center at Charité (DHZC) — Berlin

Identifiers

NCT: NCT06212193 · CLD-048

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗