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St. Joseph’s Hospital and Medical Center is pleased to participate in the Triluminate Research trial. The TRILUMINATE Pivotal Trial is studying the TriClip™ Tricuspid Valve Repair System in patients with symptomatic severe tricuspid regurgitation who are deemed appropriate for transcatheter intervention. Approximately 700 subjects will be studied at up to 80 medical centers in Europe, United States and Canada. A qualified team of doctors will monitor the patients included in the TRILUMINATE Pivotal Trial. Study participants will play an important role in helping doctors evaluate transcatheter tricuspid valve repair as an option for patients with tricuspid regurgitation.
You can still see your personal cardiologist for regular checkups and care. In addition, you will be monitored by regular follow-up exams.
CAUTION: Investigational device. Limited by federal (U.S.) law to investigational use only.
Both men and women can participate.
You may qualify if:
Tricuspid regurgitation is a condition in which the heart's tricuspid valve doesn't close properly. 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. Tricuspid regurgitation is caused by abnormalities of the surrounding valve structures most commonly due to heart disease. These abnormalities cause the tricuspid valve to enlarge and thus allow blood to flow in a backwards direction.
There are two main treatments for tricuspid regurgitation: MEDICAL THERAPY and TRICUSPID VALVE SURGERY. Prescription medicine can be taken to prevent symptoms associated with tricuspid regurgitation. Medicines include beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, vasodilators, and diuretics. Surgery to repair or replace the tricuspid valve may be an option for patients with tricuspid regurgitation. While surgery is an effective treatment for some cases of tricuspid regurgitation, it is a major procedure with associated risks. Patients who are elderly, have advanced heart failure, or have other serious medical conditions may not be appropriate for surgery.
Before you are enrolled, you will be screened to make sure you are a good candidate for the study.
Your screening may include: