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)
Status: Recruiting
Location: See all (12) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Cardiovascular Institute of Los Robles Health System
RECRUITING
Thousand Oaks
Michigan
Ascension St. John
RECRUITING
Detroit
Minnesota
Mayo Clinic Hospital (Rochester)
RECRUITING
Rochester
New York
Weill Cornell Medicine
RECRUITING
New York
Stony Brook Heart Institute
RECRUITING
Stony Brook
Ohio
The Christ Hospital
RECRUITING
Cincinnati
Pennsylvania
Lankenau Heart Institute
RECRUITING
Philadelphia
Tennessee
TriStar Centennial Medical Center
RECRUITING
Nashville
Washington
University of Washington Medical Center
RECRUITING
Seattle
Other Locations
Germany
German Heart Center at Charité (DHZC)
RECRUITING
Berlin
Helios Health Institute GmbH, Leipzig
RECRUITING
Leipzig
University Medicine Mainz
RECRUITING
Mainz
Contact Information
Primary
Chen Lereya
chen@innoventric.com
+972-52-8981783
Backup
Amir Danino
amir@innoventric.com
+972-54-7256930
Time Frame
Start Date: 2024-08-05
Estimated Completion Date: 2030-08
Participants
Target number of participants: 15
Treatments
Experimental: Innoventric Trillium™ Stent Graft
Transcatheter cross-caval tricuspid valve replacement with the Innoventric Trillium™ Stent Graft
Related Therapeutic Areas
Sponsors
Collaborators: Innoventric Inc.
Leads: Innoventric LTD