Clinical trial NCT06212193: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tricuspid Regurgitation
Tricuspid Regurgitation Functional
Keywords: Tricuspid valve
Transcatheter
Tricuspid Regurgitation
Tricuspid valve insufficiency
Lead sponsor: Innoventric LTD
Sponsor class: INDUSTRY
Collaborators: name: Innoventric Inc.
First posted: 2024-01-18
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

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

Primary outcomes:
measure: Rate of Major Adverse Events [Safety endpoint]
timeFrame: at the end of the procedure, at discharge - typically within a week, and 30 days
measure: Technical Performance
timeFrame: at the end of the procedure, at discharge - typically within a week, and 30 days
Secondary outcomes:
measure: Rate of Major Adverse Events [Safety endpoint]
timeFrame: at 3 months, 6 months, 1, 2, 3, 4, and 5 years
measure: Efficacy endpoint
timeFrame: at 30 days, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year, and 5-year
Other outcomes:
measure: Observational endpoint
timeFrame: at 30 days, 3 months, 6 months, 1, 2, 3, 4, and 5 years
Locations:
city: Thousand Oaks
country: United States
facility: Cardiovascular Institute of Los Robles Health System
state: California
city: Detroit
country: United States
facility: Ascension St. John
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Hospital (Rochester)
state: Minnesota
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: Stony Brook
country: United States
facility: Stony Brook Heart Institute
state: New York
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Lankenau Heart Institute
state: Pennsylvania
city: Nashville
country: United States
facility: TriStar Centennial Medical Center
state: Tennessee
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Mainz
country: Germany
facility: University Medicine Mainz
state: Rhineland-Palatinate
city: Leipzig
country: Germany
facility: Helios Health Institute GmbH, Leipzig
state: Saxony
city: Berlin
country: Germany
facility: German Heart Center at Charité (DHZC)
Study officials:
References: