TRILUMINATE Pivotal Trial

Landmark Study of Minimally Invasive Device for Patients with Severe Tricuspid Regurgitation

The TRILUMINATE (Clinical Trial to Evaluate Cardiovascular Outcomes In Patients Treated With the Tricuspid Valve Repair System) pivotal trial is now enrolling patients in the United States and will be enrolling in Canada and Europe, at up to 80 sites.1,2

This prospective, randomized, controlled trial will compare the investigational device (TriClip™ device) to control (medical therapy) in symptomatic patients with severe tricuspid regurgitation (TR). The objective of this trial is to1:

  • Evaluate the safety and effectiveness of the TriClip device in improving clinical outcomes in symptomatic patients with severe TR who have been determined by the site’s local heart team to be at intermediate or greater estimated risk for mortality with tricuspid valve surgery

The TriClip device is a clip-based transcatheter tricuspid valve repair (TTVR) system that is delivered via a minimally invasive procedure, with no need for cardiopulmonary bypass or arresting the heart.

TriClip/Tricuspid: pending CE Mark. Exclusively for clinical investigations. TriClip is currently in development at Abbott and being evaluated in clinical trials and is intended for use by or under the direction of a physician. Not available for sale.

ELIGIBILITY CRITERIA

Key Inclusion Criteria1

  • In the judgment of the site’s 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 (eg, diuretics)
    • Medical and/or device therapy for mitral regurgitation, atrial fibrillation, coronary artery disease, and heart failure
  • The eligibility committee (EC) 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 transthoracic echocardiogram (TTE) and confirmed by the Echocardiography Core Lab (ECL). The ECL may request a transesophageal echocardiogram (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 Heart Team concurs that the patient is at intermediate or greater estimated risk of mortality with tricuspid valve surgery
  • New York Heart Association (NYHA) Functional Class II, III, or ambulatory class IV


Key Exclusion Criteria1

  • Systolic pulmonary artery pressure (sPAP) > 70 mm Hg or fixed pre-capillary pulmonary hypertension as assessed by right heart catheterization (RHC)
  • Severe uncontrolled hypertension (systolic blood pressure [SBP] ≥ 180 mm Hg and/or diastolic blood pressure [DBP] ≥ 110 mm Hg)
  • Indication for left-sided (eg, severe aortic stenosis, severe mitral regurgitation) or pulmonary valve correction in the prior 60 days
  • Left ventricular ejection fraction (LVEF) ≤ 20%
  • Pacemaker or implantable cardioverter defibrillator (ICD) leads that would prevent appropriate placement of the TriClip device
  • Any prior tricuspid valve procedure that would interfere with placement of the TriClip device
  • Tricuspid valve leaflet anatomy which may preclude clip implantation, proper clip positioning on the leaflets, or sufficient reduction in TR. This may include:
    • Evidence of calcification in the grasping area
    • Presence of a severe coaptation defect (> 2 cm) of the tricuspid leaflets
    • Severe leaflet defect(s) preventing proper device placement
    • Ebstein anomaly
  • Tricuspid valve stenosis (tricuspid valve orifice of ≤ 1.0 cm2 and/or mean gradient ≥ 5 mm Hg as measured by the ECL)
  • Tricuspid valve anatomy not evaluable by TTE and TEE

TRILUMINATE PIVOTAL TRIAL DESIGN

TRILUMINATE is a prospective, randomized, controlled, multicenter trial that is enrolling up to 450 subjects.1,2

TRILUMINATE is a prospective, randomized, controlled, multicenter trial that is enrolling up to 450 subjects.1,2

ABOUT TRICUSPID REGURGITATION

Tricuspid regurgitation is a condition in which the valve between the two chambers on the right side of the heart does not close properly, resulting in a backward flow of blood into the right chamber of the heart, which can ultimately result in heart failure and death if left untreated.3,4Approximately 1 in 40 people over the age of 65 have moderate or severe TR.5,6 Medication is routinely prescribed, but only addresses the symptoms of TR. Surgery is an option, but is rarely performed due to the high mortality and morbidity rates associated with the procedure.4

AP2948088-WBO Rev.A

References
  1. TRILUMINATE Pivotal Trial. ClinicalTrials.gov. Accessed June 18, 2019.
  2. Data on file, Abbott Vascular.
  3. Mayo Clinic. Tricuspid valve regurgitation. Accessed June 18, 2019.
  4. Teoh ZH, et al. Prevalence of moderate-to-severe TR suitable for percutaneous intervention in TTE patients. Echo Res Pract. 2018;5(4):149-153.
  5. Topilski Y. Tricuspid valve regurgitation: epidemiology and pathophysiology. Minerva Cardioangiol. 2018;66(6):673-679.
  6. D’Arcy JL, et al. Large-scale community echocardiographic screening reveals a major burden of undiagnosed valvular heart disease in older people: the OxVALVE Population Cohort Study. Eur Heart J. 2016;37(47):3515-3522.

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