Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)

Part of paid clinical trials in Thousand Oaks, California.

Sponsor
Innoventric LTD
Study ID
NCT06212193
Status
Recruiting
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Conditions

  • Tricuspid Regurgitation
  • Tricuspid Regurgitation Functional

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Trillium™ — DEVICE
    Trillium™ Stent Graft for Cross-Caval Tricuspid Valve Replacement

Study Details

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).

Key Dates

Start date
Aug 5, 2024
Status verified
Nov 2024
Primary completion
Aug 31, 2025
Completion
Aug 31, 2030

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Innoventric Trillium™ Stent Graft
    Transcatheter cross-caval tricuspid valve replacement with the Innoventric Trillium™ Stent Graft

Primary Outcome Measure

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

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Cardiovascular Institute of Los Robles Health SystemThousand OaksCalifornia91360
Mane Arabyan
[email protected]
8057963746
Saibal Kar, Dr. (PRINCIPAL_INVESTIGATOR)
Ascension St. JohnDetroitMichigan48236
Renee Bess
[email protected]
313.343.4811
Amir Kaki (PRINCIPAL_INVESTIGATOR)
Mayo Clinic Hospital (Rochester)RochesterMinnesota55902
Mattie Reesman
[email protected]
Mackram F Eleid (PRINCIPAL_INVESTIGATOR)
Weill Cornell MedicineNew YorkNew York10065
Rose Spuhler
[email protected]
Mark Reisman, Dr. (PRINCIPAL_INVESTIGATOR)
Stony Brook Heart InstituteStony BrookNew York11794
Ruth J Tenzler Stein
[email protected]
Ahmad AlKhalil (PRINCIPAL_INVESTIGATOR)
The Christ HospitalCincinnatiOhio45219
Katy Fischesser
[email protected]
513-585-1932
Santiago Garcia, Dr (PRINCIPAL_INVESTIGATOR)
Lankenau Heart InstitutePhiladelphiaPennsylvania19096
Tisha Farinha
[email protected]
484.476.8580
William Gray (PRINCIPAL_INVESTIGATOR)
TriStar Centennial Medical CenterNashvilleTennessee37203
Bentley Abby
[email protected]
Samuel Horr, Dr. (PRINCIPAL_INVESTIGATOR)
University of Washington Medical CenterSeattleWashington98195
John Tushinski
[email protected]
James M McCabe (PRINCIPAL_INVESTIGATOR)

Find similar trials in Thousand Oaks, CA

By research site
Cardiovascular Institute of Los Robles Health System· Thousand Oaks, CAAscension St. John· Detroit, MIMayo Clinic Hospital (Rochester)· Rochester, MNWeill Cornell Medicine· New York, NYStony Brook Heart Institute· Stony Brook, NYThe Christ Hospital· Cincinnati, OH

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