Tricuspid Valve Repair for Tricuspid Regurgitation

Recruiting in Palo Alto (17 mi)

+76 other locations

Overseen ByDavid Adams, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Abbott Medical Devices

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial is testing a device called TriClip that helps fix a leaky heart valve without major surgery. It is for patients with severe valve issues who are at high risk from traditional surgery. The device clips the valve flaps together to reduce leakage and improve heart function. This procedure is less invasive and more cost-effective than medication treatment.

Eligibility Criteria

This trial is for adults over 18 with severe tricuspid regurgitation (TR), a heart valve disease, who are too high-risk for surgery. They must have stable symptoms despite treatment and be in NYHA Functional Class II-IV. Participants need suitable veins for the device and can't join if they have certain heart conditions, uncontrolled blood pressure, recent heart attacks or strokes, active infections or ulcers, allergies to the device materials or necessary medications, other serious health issues that could affect participation or life expectancy under one year.

Inclusion Criteria

Doctors can use a large catheter in my leg vein.

My heart condition limits my physical activity but I can still take care of myself.

I am 18 years old or older.

I am at a high risk for complications if I undergo tricuspid valve surgery.

I have severe symptoms despite treatment.

Exclusion Criteria

I am allergic or cannot take certain blood thinning medications.

I am on long-term dialysis.

I have a bleeding disorder or a condition that causes blood clots.

I have been diagnosed with Ebstein Anomaly.

I am currently taking antibiotics for an infection.

I have a narrowed tricuspid heart valve.

My blood pressure and heart rate are stable.

My blood pressure is not higher than 180/110 mmHg.

I had a procedure to open my heart's arteries within the last 30 days.

I have an active heart infection or rheumatic heart disease.

My heart's pumping ability is very low.

I have had a heart valve procedure that may affect TriClip device placement.

I currently have an active stomach ulcer or bleeding in my digestive tract.

Participant Groups

The TRILUMINATE Pivotal Trial is testing the safety and effectiveness of the TriClip device compared to standard medical therapy in improving outcomes for patients with severe TR. The TriClip is an investigational device designed to repair the tricuspid valve without needing open-heart surgery.

4Treatment groups

Experimental Treatment

Active Control

Group I: Single Arm GroupExperimental Treatment1 Intervention

Subjects will receive the TriClip device and will continue to be managed on medical therapy, per physician discretion.

Group II: Randomized - Device GroupExperimental Treatment1 Intervention

Subjects will undergo TriClip implantation and will continue to be managed on medical therapy, per physician discretion

Group III: Continued Access Study (CAS)Experimental Treatment1 Intervention

Subjects will undergo TriClip implantation and will continue to be managed on medical therapy, per physician discretion

Group IV: Randomized - Control GroupActive Control1 Intervention

Subjects will continue to be managed on medical therapy, per physician discretion