TRILUMINATE Pivotal Trial

Running, not enrolling · Not applicable

Conditions studied: Tricuspid Regurgitation

In brief

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).

Key facts

Study ID

NCT03904147

Run by

Abbott Medical Devices

People needed

572

Starts

2019-08-21

Expected to finish

2029-04-01

Last updated by the study team

2024-12-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Systolic pulmonary artery pressure (sPAP) > 70 mmHg or fixed pre-capillary pulmonary hypertension as assessed by right heart catheterization (RHC)
• Severe uncontrolled hypertension Systolic Blood Pressure (SBP) ≥ 180 mmHg and/or Diastolic Blood Pressure (DBP) ≥ 110 mm Hg
• Any prior tricuspid valve procedure that would interfere with placement of the TriClip(TM) device
• Indication for left-sided (e.g. severe aortic stenosis, severe mitral regurgitation) or pulmonary valve correction prior 60 days. Note: Patients with concomitant Mitral and tricuspid valve disease will have the option of getting their MR treated, and wait 60 days prior to being reassessed for the trial.
• Pacemaker or ICD leads that would prevent appropriate placement of the TriClip(TM) clip.
• Tricuspid valve stenosis - Defined as a tricuspid valve orifice of ≤ 1.0 cm2 and/or mean gradient ≥5 mmHg as measured by the ECL
• Left Ventricular Ejection Fraction (LVEF) ≤20%
• 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 (> 2cm) of the tricuspid leaflets
• Severe leaflet defect(s) preventing proper device placement
• Ebstein Anomaly - Identified by having a normal annulus position while the valve leaflets are attached to the walls and septum of the right ventricle.
• Tricuspid valve anatomy not evaluable by TTE and TEE
• Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e. noncompliant, perforated).
• MI or known unstable angina within prior 30 days
• Percutaneous coronary intervention within prior 30 days
• Hemodynamic instability defined as systolic pressure < 90 mmHg with or without afterload reduction, cardiogenic shock or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device.
• Cerebrovascular Accident (CVA) within prior 90 days
• Chronic dialysis
• Bleeding disorders or hypercoagulable state
• Active peptic ulcer or active gastrointestinal (GI) bleeding
• Contraindication, allergy or hypersensitivity to dual antiplatelet and anticoagulant therapy.
• Note: Contraindication to either antiplatelet or anticoagulant therapy (individually not both therapies) is not an exclusion criterion.
• Ongoing infection requiring current antibiotic therapy (if temporary illness, patients may enroll 30 days after discontinuation of antibiotics with no active infection).
• Known allergy or hypersensitivity to device materials

Where it is running

• St. Joseph's Hospital & Medical Center — Phoenix, Arizona, United States
• Arizona Cardiovascular Research Center — Phoenix, Arizona, United States
• Phoenix Cardiovascular Research Group — Phoenix, Arizona, United States
• Scottsdale Healthcare Shea — Scottsdale, Arizona, United States
• Tucson Medical Center — Tucson, Arizona, United States
• Scripps Green Hospital — La Jolla, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• El Camino Hospital — Mountain View, California, United States
• Providence Medical Foundation (St. Joseph Hospital) — Orange, California, United States
• Sutter Medical Center, Sacramento — Sacramento, California, United States
• University of California - Davis Medical Center — Sacramento, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• Los Robles Regional Medical Center — Thousand Oaks, California, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• Yale New Haven — New Haven, Connecticut, United States
• JFK Medical Center — Atlantis, Florida, United States
• Manatee Memorial Hospital — Bradenton, Florida, United States
• Morton Plant Valve Clinic — Clearwater, Florida, United States
• Delray Medical Center — Delray Beach, Florida, United States
• Baptist Hospital of Miami — Miami, Florida, United States
• Palm Beach Garden Medical Center — Palm Beach Gardens, Florida, United States
• Tallahassee Research Institute — Tallahassee, Florida, United States
• Piedmont Heart Institute — Atlanta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University Hospital - University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.