What side effects are associated with this type of intervention?

Common treatments for tricuspid regurgitation, particularly those similar to the VDyne System such as transcatheter tricuspid valve replacement (TTVR) and transcatheter tricuspid valve repair (TTVR), can have several side effects. These may include bleeding, infection, arrhythmias, valve dysfunction or displacement, and complications related to the access site (e.g., vascular complications). Additionally, there is a risk of stroke and other thromboembolic events. Patients may also experience adverse reactions to anesthesia used during the procedure.

What prior FDA approvals exist?

The FDA has approved several treatments for tricuspid regurgitation, primarily focusing on surgical and transcatheter interventions. Traditional surgical options include tricuspid valve repair or replacement. More recently, transcatheter tricuspid valve repair systems, such as the MitraClip (used off-label for tricuspid valve), have gained attention. These treatments aim to improve tricuspid valve function and reduce regurgitation, similar to the VDyne System currently under study.

What other types of research exist?

Promising alternatives to the VDyne System for tricuspid regurgitation include the following: 1) Transcatheter tricuspid valve repair systems such as the TriClip, which has shown positive outcomes in reducing tricuspid regurgitation. 2) The PASCAL transcatheter valve repair system, which has demonstrated efficacy in early clinical trials. 3) The Cardioband tricuspid system, which offers an adjustable annuloplasty solution for tricuspid regurgitation. These alternatives provide minimally invasive options that have shown promising results in improving tricuspid valve function and reducing regurgitation.

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Transcatheter Valve Replacement

VDyne Valve Replacement for Tricuspid Regurgitation (VISTA-US Trial)

N/A

Recruiting

Research Sponsored by VDyne, Inc.

Eligibility Criteria Checklist

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

Must have

Symptomatic severe tricuspid valve regurgitation of primary or secondary etiology

Age >18 years at time of index procedure

Must not have

Unresolved severe symptomatic carotid stenosis (> 70% by ultrasound)

Severe lung disease (severe COPD or continuous use of home oxygen or oral steroids)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month after implant to 1 year post-implant

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the VDyne System, a device designed to help treat severe tricuspid regurgitation, a condition where the heart valve doesn't close properly. It targets patients who have symptoms from this condition. The device works by helping the valve close correctly, improving blood flow in the heart. The VDyne System is part of a recent wave of devices developed to treat tricuspid regurgitation, a condition that has historically been undertreated due to high surgical risks.

Who is the study for?

This trial is for adults over 18 with severe tricuspid valve regurgitation, at least a class II on the NYHA scale. They must be stable enough to undergo the procedure and have been treated for heart failure with medication for at least 30 days. Exclusions include those with infections, certain heart conditions, drug abuse history, or unwillingness to follow study protocols.

What is being tested?

The VDyne Transcatheter Tricuspid Valve Replacement System is being tested in this trial. It aims to assess its safety and effectiveness in treating patients who suffer from significant tricuspid regurgitation—a condition where the heart's valve doesn't close tightly causing blood to flow backward.

What are the potential side effects?

While specific side effects are not listed here, similar procedures may involve risks such as bleeding, infection risk around the new valve area, potential allergic reactions to materials used like nickel or titanium if sensitivity exists, and general complications related to heart procedures.

Eligibility Criteria

Inclusion Criteria

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

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I have severe symptoms from a faulty heart valve.

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I am older than 18 years.

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My heart condition affects my daily activities but I can still walk.

Exclusion Criteria

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

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I have severe narrowing in my neck arteries causing symptoms.

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I have severe lung disease or need constant oxygen or steroids.

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I have a low white blood cell count, chronic anemia, low platelet count, or a history of bleeding disorders.

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I cannot or do not want to give consent for the study.

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My heart's pumping ability is severely reduced.

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My liver is in a very advanced stage of disease.

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I have a significant heart defect, like a hole in the heart.

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I have not had a heart attack in the last 30 days.

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I have a blood clotting disorder that cannot be controlled with medication.

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I am allergic or react badly to certain medications used during or after procedures.

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My kidney function is very low or I am on dialysis.

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My doctor does not expect my treatment to work.

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I am not willing to receive blood transfusions.

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I have a serious issue with my tricuspid heart valve.

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I have a serious heart valve problem that needs treatment, but it's not the tricuspid valve.

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I am unable or unwilling to follow the study's required tests and visits.

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I have severe hardening of my heart's tricuspid valve.

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I have no surgeries planned 30 days before or after the implant procedure.

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I have serious heart artery problems needing treatment.

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I need drugs or devices to help my heart pump during my planned procedure.

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I cannot tolerate blood thinners due to side effects that can't be managed.

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My heart's right ventricle is not working well.

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I have had previous heart valve surgery or treatment that prevents me from getting the VDyne Valve.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month after implant to 1 year post-implant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month after implant to 1 year post-implant

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month after implant to 1 year post-implant for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Changes in in quality of life (KCCQ score)

The percentage of subjects with Device- and/or Procedure-related Major Adverse Events (MAE) within 30 days of the procedure, as classified by the Clinical Events Committee (CEC).

Secondary study objectives

Change in tricuspid valve regurgitation compared to baseline as measured by the Imaging Core Labs

Changes in functional capacity (6-minute walk test)

Changes in in quality of life (KCCQ score).

+4 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: VDyne System Treatment ArmExperimental Treatment1 Intervention

Device

0 / 26Eligibility 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 transcatheter interventions. Medical management often involves diuretics to reduce fluid overload and medications to manage underlying conditions like heart failure. Surgical repair, such as annuloplasty, aims to tighten or reinforce the tricuspid valve ring to prevent backflow. Transcatheter interventions, like the VDyne System, focus on minimally invasive techniques to improve valve function and reduce regurgitation. These treatments are crucial for TR patients as they help alleviate symptoms, improve heart function, and reduce the risk of complications such as heart failure and atrial fibrillation.