Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorInnoventric LTD

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

Sponsors and collaborators

Innoventric LTD

Lead sponsor

Innoventric Inc.

Collaborator