UC Davis Health cardiologists are testing the safety and effectiveness of a device that could expand options for treating a leaky tricuspid heart valve, a condition known as tricuspid regurgitation.
Called the TriClip, it is the first device developed to fix the valve using a catheter instead of surgery. While there is a catheter-based system for repairing the nearby mitral valve when it leaks, the tricuspid valve is trickier, according to interventional cardiologist and study principal investigator Gagan Singh.
“It’s location, thinness and variability make it harder to repair without cutting open the chest,” Singh said. “My only choices for patients with tricuspid regurgitation are monitoring, providing higher and higher doses of medications, and referring them to surgeons when symptoms become severe. We decided to be part of the process of finding a new alternative.”
It is estimated that one in 30 people over age 65 in the U.S. have moderate to severe tricuspid regurgitation. It occurs when leaflets inside the valve no longer create a tight enough seal to efficiently circulate blood, causing it to pool in parts of the heart where it shouldn’t. The most common first symptoms are fatigue and breathlessness, which can progress to arrhythmia and heart failure.
The TriClip and its delivery system are designed specific to the position, location and shape of the tricuspid valve. With the patient under general anesthesia, the device is delivered to the heart through a catheter, starting in the groin and guided by X-ray and ultrasound. Once in place, the clip brings together portions of the leaflets, improving the seal and reducing the leaking.
Singh and the UC Davis structural heart disease team are currently enrolling patients in the study. Half of the participants will receive the new device and half will have standard medical management. Both groups will be compared over five years for differences in disease symptoms and side effects. The results will be combined with those from heart centers throughout the U.S. to determine if the device improves symptoms and is as safe (or safer) than medical management.
The TriClip was developed by study sponsor Abbott. Additional information and criteria for enrolling in the study are available on UC Davis Health Study Pages, or by contacting Kimberley Book at firstname.lastname@example.org or 916-734-5639.
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