Research Study: TRILUMINATE Pivotal
Condition:
tricuspid regurgitation
Study Sponsor: Abbott Vascular
Study Investigator: Paul Sorajja, MD
Study Contact: Kate Jappe
kate.jappe@allina.com
612-863-7347
Every research study comes with its own unique risks and benefits; the study team will assess whether you’re an eligible candidate and ensure you’re provided with all the information you need to decide if participating is right for you.
About this Study:

The primary objective of this trial is to demonstrate the safety and effectiveness of the TriClip device in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR), who are at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve surgery. This randomized controlled trial will compare the investigational device (TriClip device) to Control (Medical Therapy).
Eligibility Criteria:

  • In the judgment of the site local heart team, subject has been adequately treated per applicable standards (including medical management) and stable for at least 30 days as follows:
    • Optimized medical therapy for treatment of TR (e.g. diuretics).
    • Medical and/or device therapy, for mitral regurgitation, atrial fibrillation, coronary artery disease and heart failure.
    • The Eligibility Committee will confirm that the subject has been adequately treated medically.
  • Subject is symptomatic with Severe TR despite being optimally treated as described above. TR severity is determined by the assessment of a qualifying TTE and confirmed by the ECL. The ECL will also request a TEE to confirm TR etiology. Note: If any cardiac procedure(s) occur after eligibility was determined, TR severity will need to be re-assessed 30 days after the cardiac procedure(s).
  • The cardiac surgeon of the site local heart team concur that the patient is at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve surgery.
  • New York Heart Association (NYHA) Functional Class II, III or ambulatory class IV
  • In the judgment of the TriClip(TM) implanting Investigator, femoral vein access is determined to be feasible and can accommodate a 25 Fr catheter.
  • Age ≥18 years at time of consent.
  • Subject must provide written informed consent prior to any trial related procedure.

Interested in participating in this study?

Reach out to the study contact directly, or fill out this form and we will contact you and assess whether you are an eligible candidate!