Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)
NCT ID: NCT06212193
Last Updated: 2025-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
15 participants
INTERVENTIONAL
2024-08-05
2030-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Innoventric Trillium™ Stent Graft
Transcatheter cross-caval tricuspid valve replacement with the Innoventric Trillium™ Stent Graft
Trillium™
Trillium™ Stent Graft for Cross-Caval Tricuspid Valve Replacement
Interventions
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Trillium™
Trillium™ Stent Graft for Cross-Caval Tricuspid Valve Replacement
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
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Innoventric Inc.
UNKNOWN
Innoventric LTD
INDUSTRY
Responsible Party
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Locations
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Cardiovascular Institute of Los Robles Health System
Thousand Oaks, California, United States
Ascension St. John
Detroit, Michigan, United States
Mayo Clinic Hospital (Rochester)
Rochester, Minnesota, United States
Weill Cornell Medicine
New York, New York, United States
Stony Brook Heart Institute
Stony Brook, New York, United States
The Christ Hospital
Cincinnati, Ohio, United States
Lankenau Heart Institute
Philadelphia, Pennsylvania, United States
TriStar Centennial Medical Center
Nashville, Tennessee, United States
University of Washington Medical Center
Seattle, Washington, United States
University Medicine Mainz
Mainz, Rhineland-Palatinate, Germany
Helios Health Institute GmbH, Leipzig
Leipzig, Saxony, Germany
German Heart Center at Charité (DHZC)
Berlin, State of Berlin, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CLD-048
Identifier Type: -
Identifier Source: org_study_id
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