What side effects are associated with this type of intervention?

Common side effects of tricuspid valve replacement via a transfemoral approach, such as the Cardiovalve Transfemoral System, include bleeding, infection, vascular complications, and arrhythmias. There are also risks of device malfunction or migration and potential need for re-intervention. Long-term outcomes and specific side effects are still being studied in clinical trials.

What prior FDA approvals exist?

The FDA has approved several treatments for tricuspid regurgitation, particularly focusing on transcatheter approaches. One notable approval is the MitraClip device, which, while primarily used for mitral valve repair, has been adapted for off-label use in tricuspid valve repair. Additionally, the TriClip device, specifically designed for tricuspid valve repair, has gained attention. These devices, similar to the Cardiovalve Transfemoral System, offer minimally invasive options for patients with tricuspid regurgitation, providing alternatives to traditional open-heart surgery.

What other types of research exist?

Promising novel alternatives to the Cardiovalve Transfemoral System for tricuspid regurgitation patients in 2024 include: 1) The TriClip device, which is a transcatheter tricuspid valve repair system that uses a clip to approximate the leaflets of the tricuspid valve, improving coaptation and reducing regurgitation. 2) The PASCAL system, another transcatheter repair device that uses clasps and paddles to grasp and coapt the tricuspid valve leaflets. 3) The EVOQUE tricuspid valve replacement system, which is a transcatheter valve designed specifically for the tricuspid position, offering a less invasive alternative to open-heart surgery. These alternatives are supported by recent clinical trials and expert recommendations.

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Prosthetic Valve

Cardiovalve System for Tricuspid Regurgitation

N/A

Waitlist Available

Research Sponsored by Boston Biomedical Associates

Eligibility Criteria Checklist

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

Must have

Participant distance of 6 minute walk test (6MWT) ≥ 60 m

Participant has severe, symptomatic tricuspid regurgitation (TR) ≥ 3+ based upon echocardiography, as assessed by Independent core laboratory

Must not have

UNOS Status 1 heart transplant or prior orthotropic heart transplantation

Female patient of child-bearing potential

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days, 3 months, 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new device called the Cardiovalve Transfemoral System, which replaces a faulty heart valve through a minimally invasive procedure. It targets patients who need a tricuspid valve replacement but may not be suitable for open-heart surgery. The study will check the safety and effectiveness of the device over a short period and follow patients for an extended time to see long-term results.

Who is the study for?

This trial is for adults aged 18-85 with severe, symptomatic tricuspid regurgitation who've been treated for related heart conditions. They must be able to walk at least 60 meters and have a left ventricular ejection fraction of ≥35%. Exclusions include significant coronary artery disease, prior valve surgeries, recent strokes, active infections or planned procedures within the next month.

What is being tested?

The Cardiovalve Transfemoral System is being tested in this study to replace the tricuspid valve without open-heart surgery. The trial will assess safety and performance after 30 days and monitor patients' health over five years.

What are the potential side effects?

Potential side effects may include complications from the procedure like bleeding or infection, adverse reactions to materials in the device or medications used during implantation, irregular heart rhythms, or issues with valve function post-operation.

Eligibility Criteria

Inclusion Criteria

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

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I can walk 60 meters or more in 6 minutes.

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I have severe heart valve leakage as confirmed by an ultrasound.

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My heart condition limits my physical activity but I can still perform light tasks.

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I am between 18 and 85 years old.

Exclusion Criteria

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

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I am a heart transplant recipient or urgently need one.

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I am a woman who could become pregnant.

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I do not have a non-heart related illness limiting my life to under a year.

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I am unable or unwilling to sign a consent form for this study.

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I am receiving treatment for severe heart artery disease.

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My heart's structure is not fit for a Cardiovalve implant.

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I need surgery for a heart valve problem.

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My liver is not working well (MELD score over 10).

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I have not had heart valve infection in the past year.

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I have severe COPD or need to use oxygen at home all the time.

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I need help with my daily activities due to my condition.

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I have a blood clotting disorder or low platelet count (below 90,000).

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I have had surgery or a procedure on my tricuspid valve.

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I do not have unstable heart failure or need IV medication to help my heart pump.

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I have chronic anemia with hemoglobin levels below 9.

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I am allergic to certain medical device materials, vitamin K blockers, or contrast agents.

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I cannot have an implant due to a blood clot in my veins or having a vena cava filter.

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I have a condition affecting my tricuspid valve.

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I have a serious heart valve problem on the left side that needs treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days, 3 months, 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days, 3 months, 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days, 3 months, 6 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

1. Primary Performance Endpoint - Technical Success of Cardiovalve Delivery and Function in each participant

Primary Performance Endpoint - Clinical Performance - Reduction in Tricuspid Regurgitation severity measured using Echocardiography and compared to baseline

Primary Safety Endpoint (Patient Based) Participants Implanted without Major Device Related Adverse Events through thirty days

Secondary study objectives

Secondary Performance Endpoint - 6 minute walk test

Secondary Performance Endpoint - Cusp Insufficiency

Secondary Performance Endpoint - Kansas City Cardiomyopathy Questionnaire

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Cardiovalve Transfemoral Tricuspid ValveExperimental Treatment1 Intervention

Replacement (Implant) delivered through a transfemoral access

0 / 23Eligibility 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

Common treatments for Tricuspid Regurgitation (TR) include medical management, surgical repair, and valve replacement. Medical management often involves diuretics to reduce fluid overload and medications to manage underlying conditions like heart failure. Surgical repair techniques, such as annuloplasty, aim to tighten or reinforce the valve ring. Valve replacement, including the Cardiovalve Transfemoral System, involves replacing the damaged tricuspid valve with a prosthetic one via a minimally invasive approach. This method is particularly significant for TR patients as it offers a less invasive option compared to open-heart surgery, potentially reducing recovery time and associated risks. The Cardiovalve system's transfemoral approach allows for precise placement and improved valve function, which is crucial for enhancing patient outcomes and quality of life.