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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

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 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

Trial Design

1Treatment groups
Experimental Treatment
Group I: VDyne System Treatment ArmExperimental Treatment1 Intervention
Device

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.

Find a Location

Who is running the clinical trial?

VDyne, Inc.Lead Sponsor
1 Previous Clinical Trials
40 Total Patients Enrolled

Media Library

VDyne Transcatheter Tricuspid Valve Replacement System (Transcatheter Valve Replacement) Clinical Trial Eligibility Overview. Trial Name: NCT05848284 — N/A
Tricuspid Regurgitation Research Study Groups: VDyne System Treatment Arm
Tricuspid Regurgitation Clinical Trial 2023: VDyne Transcatheter Tricuspid Valve Replacement System Highlights & Side Effects. Trial Name: NCT05848284 — N/A
VDyne Transcatheter Tricuspid Valve Replacement System (Transcatheter Valve Replacement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05848284 — N/A
~20 spots leftby Nov 2025