About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Trillium™

Treatment groups

15 Participants
are divided into 1 treatment group

Locations

12
Germany
University Medicine Mainz55131, MainzRhineland-Palatinate, Germany
Helios Health Institute GmbH, Leipzig04103, LeipzigSaxony, Germany
German Heart Center at Charité (DHZC)13353, BerlinState of Berlin, Germany
United States
California
Cardiovascular Institute of Los Robles Health System91360, Thousand Oaks United States

Sponsors and collaborators

Innoventric LTD

Lead sponsor

Innoventric Inc.

Collaborator