Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)

• ClinicalTrials.gov Identifier: NCT06212193
• Recruitment Status: Not yet recruiting
• First Posted: January 18, 2024
• Last Update Posted: January 18, 2024
• Sponsor: Innoventric LTD
• Information provided by (Responsible Party): Innoventric LTD

Study Description

Brief 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).

Condition or disease	Intervention/treatment	Phase
Tricuspid Regurgitation; Tricuspid Regurgitation Functional	Device: Trillium™	Not Applicable

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 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Estimated Study Start Date: February 2024
• Estimated Primary Completion Date: February 2025
• Estimated Study Completion Date: February 2030

Arms and Interventions

Arm	Intervention/treatment
Experimental: Innoventric Trillium™ Stent Graft; Transcatheter cross-caval tricuspid valve replacement with the Innoventric Trillium™ Stent Graft	Device: Trillium™; Trillium™ Stent Graft for Cross-Caval Tricuspid Valve Replacement

Outcome Measures

Primary Outcome Measures :

1. Rate of Major Adverse Events [Safety endpoint] [ Time Frame: at the end of the procedure, at discharge - typically within a week, and 30 days ]

   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

2. Technical Performance [ Time Frame: at the end of the procedure, at discharge - typically within a week, and 30 days ]

   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]

Secondary Outcome Measures :

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

   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]

Other Outcome Measures:

1. Observational endpoint [ Time Frame: at 30 days, 3 months, 6 months, 1, 2, 3, 4, and 5 years ]
   All-cause mortality

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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< 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

Contacts and Locations

Contacts

Contact: Chen Lereya; +972-52-8981783; chen@innoventric.com

Contact: Amir Danino; +972-54-7256930; amir@innoventric.com

Sponsors and Collaborators

Innoventric LTD

More Information

• Responsible Party: Innoventric LTD
• ClinicalTrials.gov Identifier: NCT06212193
• Other Study ID Numbers: CLD-048
• First Posted: January 18, 2024
• Last Update Posted: January 18, 2024
• Last Verified: December 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

Keywords provided by Innoventric LTD:

Tricuspid valve; Transcatheter; Tricuspid Regurgitation; Tricuspid valve insufficiency

Additional relevant MeSH terms:

Tricuspid Valve Insufficiency; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases