Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)

Tricuspid Regurgitation Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06212193
• Other study ID #: CLD-048
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2024
• Est. completion date: February 2030

Study information

• Verified date: December 2023
• Source: Innoventric LTD
• Contact: Chen Lereya
• Phone: +972-52-8981783
• Email: chen[@]innoventric.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: February 2030
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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< 100,000/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

Related Conditions & MeSH terms

• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Innoventric LTD

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Observational endpoint	All-cause mortality	at 30 days, 3 months, 6 months, 1, 2, 3, 4, and 5 years
Primary	Rate of Major Adverse Events [Safety endpoint]	Rate of device or procedure-related Major Adverse Events (MAEs); And; Rate of unplanned surgery or re-intervention due to a life-threatening device or procedure failure	at the end of the procedure, at discharge - typically within a week, and 30 days
Primary	Technical Performance	Successful access, delivery, and retrieval of the Trillium™ delivery system, device is anchored both in SVC and IVC [at the end of the procedure]; And; No need for re-intervention due to device valve regurgitation or para-stent leak [at discharge, and 30 days]	at the end of the procedure, at discharge - typically within a week, and 30 days
Secondary	Rate of Major Adverse Events [Safety endpoint]	Composite of all device or procedure-related MAEs [at 3 months, 6 months, 1, 2, 3, 4, and 5 years].; Device thrombosis, evaluated by Echocardiography [at 30 days, 6 months, 1, 2, and 4 years].; Device Migration as evaluated by Echocardiography or CMR [at 6 months]	at 3 months, 6 months, 1, 2, 3, 4, and 5 years
Secondary	Efficacy endpoint	One or more of the following-; TR grade as measured on the device valves by Echocardiography, or reduction in peak CVP as measured by right heart catheterization [at the end of the procedure]; TR grade as measured on the device valves by Echocardiography [at 30 days, 6-month, 1-year, 2-year, and 4-year]; Rate of hospitalizations for HF [at 6-month, and 1-year]; HF functional class (NYHA) [at 30 days, 3-month, 6-month,1-year, 2-year, 3-year, 4-year, and 5-year]; Six-minute walk test (6MWT) [at 30 days, 6-month, 1-year, 2-year, and 4-year]; The Kansas City Cardiomyopathy Questionnaire (KCCQ) [at 30 days, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year, and 5-year]; Patient Global Assessment (PGA) for Tricuspid Regurgitation Valve Treatment [at 30 days, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year, and 5-year]	at 30 days, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year, and 5-year