What is the mechanism of action of this treatment?

The TriClip device works by clipping the tricuspid valve leaflets together, thereby reducing the backflow of blood (regurgitation) into the right atrium. This mechanical intervention directly addresses the structural incompetence of the tricuspid valve, which is the primary cause of tricuspid regurgitation. By improving valve function, the TriClip device helps to alleviate symptoms such as fatigue and swelling, reduce the risk of heart failure, and improve overall quality of life for patients. This approach is particularly beneficial for patients who are at high risk for traditional surgical interventions.

What side effects are associated with this type of intervention?

The most common treatments for tricuspid regurgitation, particularly those involving devices like the TriClip, include percutaneous tricuspid valve repair and surgical interventions. Known side effects of these treatments can include bleeding, infection, arrhythmias, and device-related complications such as device embolization or malfunction. Additionally, patients may experience procedural risks such as vascular complications and adverse reactions to anesthesia.

What prior FDA approvals exist?

As of now, there are limited FDA-approved treatments specifically targeting tricuspid regurgitation through methods similar to the TriClip device, which involves clipping the tricuspid valve leaflets to reduce regurgitation. The TriClip device is currently being studied for its safety and effectiveness in improving clinical outcomes in patients with severe tricuspid regurgitation. Traditional treatments for tricuspid regurgitation have primarily included medical management and surgical interventions such as valve repair or replacement, but less invasive options like the TriClip are still under investigation.

What other types of research exist?

Promising novel alternatives to the TriClip device for tricuspid regurgitation include: 1) Transcatheter tricuspid valve replacement (TTVR) devices such as the EVOQUE system, which is designed for minimally invasive valve replacement. 2) The PASCAL transcatheter valve repair system, which uses a different mechanism to grasp and coapt the tricuspid valve leaflets. 3) The Cardioband tricuspid system, which involves an adjustable band to reshape the tricuspid annulus and reduce regurgitation. These alternatives are in various stages of clinical evaluation and have shown potential in improving clinical outcomes for tricuspid regurgitation patients.

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Tricuspid Valve Repair Device

Tricuspid Valve Repair for Tricuspid Regurgitation

N/A

Waitlist Available

Led By David Adams, MD

Research Sponsored by Abbott Medical Devices

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Femoral vein access is determined to be feasible and can accommodate a 25 Fr catheter

New York Heart Association (NYHA) Functional Class II, III or ambulatory class IV

Must not have

Contraindication, allergy or hypersensitivity to dual antiplatelet and anticoagulant therapy

Chronic dialysis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects from using the TriClip may include bleeding complications due to required antiplatelet/anticoagulant therapy, risks associated with catheter insertion such as vascular injury or infection, possible damage to heart structures during placement of the clip, and potential need for additional procedures if initial repair isn't successful.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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Doctors can use a large catheter in my leg vein.

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

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I am 18 years old or older.

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

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I have severe symptoms despite treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am allergic or cannot take certain blood thinning medications.

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I am on long-term dialysis.

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

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I have been diagnosed with Ebstein Anomaly.

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I am currently taking antibiotics for an infection.

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I have a narrowed tricuspid heart valve.

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My blood pressure and heart rate are stable.

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

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

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I have an active heart infection or rheumatic heart disease.

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My heart's pumping ability is very low.

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

For Randomized Cohort: Hierarchical Composite of All-cause Death or Tricuspid Valve Surgery, Heart Failure Hospitalizations, and KCCQ Improvement

For Single-Arm Cohort: Rate of Survival Through 12 Months With a Quality of Life Improvement (Assessed Using KCCQ Overall Score) of at Least 10 Points Compared to Baseline.

Secondary study objectives

For Randomized Cohort - Device Group Only: Rate of Kaplan-Meier Estimate (SE) of Freedom From Major Adverse Events (MAE) Occurring Within 30 Days Post-procedure

For Randomized Cohort: Change in 6 Minute Walk Test (6MWT) From Baseline to 12 Months

For Randomized Cohort: Change in Quality of Life as Assessed by KCCQ Score

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

0 / 18Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The TriClip device works by clipping the tricuspid valve leaflets together, thereby reducing the backflow of blood (regurgitation) into the right atrium. This mechanical intervention directly addresses the structural incompetence of the tricuspid valve, which is the primary cause of tricuspid regurgitation. By improving valve function, the TriClip device helps to alleviate symptoms such as fatigue and swelling, reduce the risk of heart failure, and improve overall quality of life for patients. This approach is particularly beneficial for patients who are at high risk for traditional surgical interventions.