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Clinical Trial to Evaluate Cardiovascular Outcomes in Patients Treated with the Tricuspid Valve Repair System Pivotal (TRILUMINATE Pivotal)

Study Type/Phase: Pivotal, Randomized, Single Arm
Status: Recruiting

The tricuspid heart valve separates the right lower heart chamber (the right ventricle) from the right upper heart chamber (right atrium). Tricuspid regurgitation (TR) is a disorder in which this valve does not close tight enough. When this happens, some blood flows backward through the valve. The heart must then work harder to push blood through the body which can cause fatigue, shortness of breath, and worsening heart failure.  Medical treatment primarily revolves around the use of diuretics and medical management; however, a proportion of patients continue to progress and suffer from the symptoms of TR.

The same disorder occurs on the left side of the heart, known as mitral regurgitation (MR).  Abbott, the sponsor of this trial, developed an effective new treatment for severe mitral regurgitation that does not require open-heart surgery and has been FDA approved for commercial use.  For this trial, Abbott has modified the mitral valve device to treat tricuspid regurgitation in the same way, through transcatheter intervention.

The purpose of this research study is to compare the performance of the investigational tricuspid valve repair system TriClipTM plus optimal drug therapy with optimal drug therapy alone.

Speak with your doctor to determine whether you meet the following criteria for participation in this study.

Inclusion Criteria Exclusion Criteria
  • You have been diagnosed with symptomatic severe tricuspid regurgitation
  • It has been determined by the study site’s heart team that transcatheter intervention is appropriate for you.
  • No prior tricuspid valve procedure that would interfere with the TriClip device
  • Myocardial infarction or unstable angina within 30 days
  • Chronic dialysis

Principal Investigator

Chad Rammohan MD, Deepu Nair MD, and Geoffrey Yoon, MD

Sponsor

Abbott 

NCT Number

NCT03904147

Contact

Janet Lamm, Sr. Clinical Research Coordinator
650-962-4566
Janet_Lamm@elcaminohealth.org

For more information about this clinical trial, including trial status, eligibility and full trial listing, visit www.clinicaltrials.gov.

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