Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)

March 5, 2025 updated by: Innoventric LTD

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)

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • Recruiting
        • German Heart Center at Charité (DHZC)
        • Contact:
        • Contact:
          • Tobias Daniel Trippel, Dr.
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Germany, 55131
    • Saxony
      • Leipzig, Saxony, Germany, 04103
  • United States
    • California
      • Thousand Oaks, California, United States, 91360
        • Recruiting
        • Cardiovascular Institute of Los Robles Health System
        • Contact:
        • Contact:
          • Saibal Kar, Dr.
    • Michigan
      • Detroit, Michigan, United States, 48236
        • Recruiting
        • Ascension St. John
        • Contact:
        • Contact:
          • Amir Kaki
    • Minnesota
      • Rochester, Minnesota, United States, 55902
        • Recruiting
        • Mayo Clinic Hospital (Rochester)
        • Contact:
        • Contact:
          • Mackram F Eleid
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Weill Cornell Medicine
        • Contact:
        • Contact:
          • Mark Reisman, Dr.
      • Stony Brook, New York, United States, 11794
    • Ohio
      • Cincinnati, Ohio, United States, 45219
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19096
        • Recruiting
        • Lankenau Heart Institute
        • Contact:
        • Contact:
          • William Gray
    • Tennessee
      • Nashville, Tennessee, United States, 37203
    • Washington
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington Medical Center
        • Contact:
        • Contact:
          • James M McCabe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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]
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

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Observational endpoint
Time Frame: at 30 days, 3 months, 6 months, 1, 2, 3, 4, and 5 years
All-cause mortality
at 30 days, 3 months, 6 months, 1, 2, 3, 4, and 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innoventric LTD

Collaborators

Innoventric Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2024

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2030

Study Registration Dates

First Submitted

December 20, 2023

First Submitted That Met QC Criteria

January 17, 2024

First Posted (Actual)

January 18, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 5, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLD-048

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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