VDyne Valve Replacement for Tricuspid Regurgitation

(VISTA-US Trial)

Recruiting at 10 trial locations

Overseen By Jeya Satheesh

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VDyne, Inc.

Must be taking: Diuretics

Disqualifiers: Severe COPD, Severe RV dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Implant to 30 days post-procedure

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the VDyne Transcatheter Tricuspid Valve Replacement System to treat severe tricuspid regurgitation, where the heart's tricuspid valve doesn't close properly, causing blood to flow backward. The researchers aim to determine if this treatment is safe and effective for individuals with noticeable symptoms like difficulty breathing or extreme fatigue. It suits those who have managed heart failure with medication for at least 30 days but still experience troublesome symptoms. As an unphased trial, this study provides patients the opportunity to access innovative treatment options not yet widely available.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you must be on stable heart failure medication, including a diuretic, for at least 30 days before the procedure.

What prior data suggests that the VDyne System is safe for treating tricuspid regurgitation?

Research suggests that the VDyne Transcatheter Tricuspid Valve Replacement System could safely treat tricuspid regurgitation (TR). One study indicated that this method might completely relieve TR. However, concerns exist, such as the risk of blood clots forming around the valve. Additionally, long-term safety information is not yet available, making the valve's long-term effectiveness uncertain.

As the study is in an early phase, researchers are still assessing its safety. This stage typically involves a smaller group of participants to closely monitor any side effects. While early evidence indicates the device might be well-tolerated, more information is needed to fully understand its safety in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the VDyne Transcatheter Tricuspid Valve Replacement System because it offers a minimally invasive alternative to open-heart surgery for treating tricuspid regurgitation. Unlike traditional surgical options, such as valve repair or replacement through major surgery, the VDyne system uses a catheter-based approach, which means it can be delivered through a small incision. This method potentially reduces recovery time and lowers the risk of complications associated with more invasive procedures. Additionally, it provides a new option for patients who may not be candidates for surgery, expanding treatment possibilities for those with this heart condition.

What evidence suggests that the VDyne System is effective for tricuspid regurgitation?

Research has shown that the VDyne Transcatheter Tricuspid Valve Replacement System, which participants in this trial will receive, may help treat severe tricuspid regurgitation. This condition occurs when the heart's tricuspid valve doesn't close properly, causing blood to leak backward into the heart. In early studies with a small group of patients, researchers successfully implanted the VDyne Valve, leading to improvements in their health. This system replaces the faulty valve without requiring open-heart surgery, offering a less invasive treatment option. Transcatheter valve replacement methods like this one are promising alternatives and may provide better results than traditional surgery. While more research is needed, early findings suggest that the VDyne system could be a helpful option for patients with this condition. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have severe symptoms from a faulty heart valve.

I am older than 18 years.

Clinical Screening Committee (CSC) and Imaging Core Labs confirm suitability for treatment with the VDyne System

Exclusion Criteria

I have severe narrowing in my neck arteries causing symptoms.

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

Currently participating in an investigational drug or device trial that has not reached its primary endpoint or is likely to interfere with this study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the VDyne Transcatheter Tricuspid Valve Replacement System

Implant to 30 days post-procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• VDyne Transcatheter Tricuspid Valve Replacement System

Trial Overview 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.

How Is the Trial Designed?

Group I: VDyne System Treatment Arm Experimental Treatment 1 Intervention

Device

Who Is Running the Clinical Trial?

VDyne, Inc.

Lead Sponsor

Trials

2

Recruited

70+

Published Research Related to This Trial

Transcatheter valve replacement (TVR) has emerged as a safe and effective treatment option for patients with congenital heart disease, particularly for those with dysfunctional right-sided cardiac valves, showing comparable safety and short-term outcomes to traditional surgical valve replacement.

Currently, two transcatheter valves are approved for specific uses, and ongoing technological advancements are expected to expand the applicability of TVR to a broader range of patients with repaired congenital heart disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter Valve Replacement for Right-sided Valve Disease in Congenital Heart Patients. Gales, J., Krasuski, RA., Fleming, GA.[2018]

In a study involving 5 patients with severe tricuspid regurgitation (TR), the novel GATE System for transcatheter tricuspid valve replacement was successfully implanted, leading to a significant reduction in TR severity to ≤2+.

Follow-up results showed that most patients experienced right ventricular remodeling, increased cardiac output, and improved functional status, indicating the potential efficacy of this device in treating severe TR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Single-Site Experience With Transcatheter Tricuspid Valve Replacement. Hahn, RT., George, I., Kodali, SK., et al.[2020]

Transcatheter tricuspid valve replacement is a viable treatment option for high-risk patients with degenerated tricuspid prostheses, offering an alternative to traditional surgery.

Both transjugular and transfemoral approaches are effective, with the transfemoral method being more commonly used, as demonstrated in a challenging case where a long sheath was utilized for valve delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tough Crossing: A Challenging Case of Valve-in-Valve Transcatheter Tricuspid Valve Replacement. Gupta, T., Lin, CH., Kleiman, NS., et al.[2023]

In a study of 194 heart failure patients who underwent LVAD implantation, those who received concomitant tricuspid valve intervention (TVI) saw a significant reduction in moderate or greater tricuspid regurgitation (TR) from 52% to about 20% within the first 6 months after surgery.

Despite the improvement in TR for patients who had TVI, there was no difference in overall survival or heart failure readmission-free survival compared to those without TVI, indicating that while TVI can reduce TR, it does not necessarily lead to better long-term clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Concomitant Tricuspid Valve Surgery With Left Ventricular Assist Device Implantation. Fujino, T., Imamura, T., Nitta, D., et al.[2021]

Transcatheter interventions for severe tricuspid regurgitation are still largely investigational, with the MitraClip being the most commonly used device, showing better effectiveness when the gap between leaflets is less than 7 mm.

The Tricuspid Cardioband has received CE mark approval and shows promising short-term results, highlighting the importance of careful patient selection and assessment of disease severity for successful interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter tricuspid valve intervention: a practical algorithm for patient selection. Ho, EC., Ong, G., Fam, NP.[2020]

In a study of 35 patients who underwent tricuspid valve replacement (TVR), the 30-day mortality rate was 20%, with significant risk factors including severe pulmonary hypertension and low arterial blood pressure.

Despite the high early mortality, long-term survival rates were promising, with 54.3% of patients surviving at 10 years and a significant improvement in functional status, as measured by the New York Heart Association class.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tricuspid valve replacement: an analysis of risk factors and outcomes. Civelek, A., Ak, K., Akgün, S., et al.[2008]

Transcatheter tricuspid valve-in-valve (VIV) replacement using balloon-expandable valves showed significant improvements in heart function, including increased tricuspid valve area and reduced right atrial pressure, in a small group of 4 patients.

At a median follow-up of 32 months, all patients remained alive and experienced improved functional status, with low rates of complications and well-maintained valve performance, indicating the procedure's potential safety and efficacy for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term follow-up after trans-catheter tricuspid valve-in-valve replacement with balloon-expandable aortic valves. Scarsini, R., Lunardi, M., Pesarini, G., et al.[2017]

Tricuspid regurgitation (TR) is common in heart failure patients, and valve replacement is essential for those with irreparable valves or high risk of future failure.

The manuscript outlines a specific technique for tricuspid valve replacement using a bioprosthetic valve, which may improve outcomes for patients with significant TR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tricuspid valve replacement with a bioprosthetic valve. Russell, HM., McCarthy, PM., Lee, R., et al.[2016]

Transcatheter tricuspid valve interventions, particularly replacement, are emerging as promising treatments for severe tricuspid regurgitation, especially in elderly patients where traditional methods have limited efficacy.

These interventions may improve both quality of life and survival rates, making them a potentially preferred option over conventional surgery and repair methods for patients who cannot benefit from repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on Transcatheter Tricuspid Valve Replacement Therapies. Goldberg, YH., Ho, E., Chau, M., et al.[2021]

Tricuspid valve replacement (TVR) in heart transplant patients appears to be a safe procedure, with only one death reported among nine patients studied over six months, specifically in a patient with severe graft atherosclerosis.

Post-TVR, patients showed significant improvements in kidney function (reduced serum creatinine), nutritional status (increased albumin levels), and overall health (decreased furosemide dosage), suggesting that TVR may alleviate symptoms of tricuspid regurgitation and enhance quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tricuspid valve replacement after cardiac transplantation. Raghavan, R., Cecere, R., Cantarovich, M., et al.[2022]

In a study of 26 patients who underwent bioprosthetic tricuspid valve replacement due to severe infective endocarditis, there was no early 30-day hospital mortality, indicating a safe procedure.

At a mean follow-up of 5.7 years, the procedure showed excellent long-term outcomes with 100% freedom from cardiac death and 92.3% freedom from valve-related redo operations, demonstrating its efficacy in managing severe tricuspid valve infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bioprosthetic tricuspid valve replacement for tricuspid valve endocarditis secondary to infected endocardial pacemaker leads. Xu, Z., Shi, Q., Mei, J., et al.[2017]

Transcatheter tricuspid valve-in-valve (TTViV) replacement was performed successfully in 12 high-risk patients, leading to significant improvements in heart function and echocardiographic measures over a mean follow-up of 3.17 years.

The procedure resulted in a notable decrease in transvalvular mean gradient pressure and tricuspid regurgitation gradient, with no significant leakage observed, indicating that TTViV is a safe and effective treatment for patients with degenerated bioprosthetic tricuspid valves.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mid to Long-Term Echocardiographic Follow-up of Patients Undergoing Transcatheter Tricuspid Valve-in-Valve Replacement for Degenerated Bioprosthetic Valves: First Single-Center Report from Iran. Sahebjam, M., Haji Zeinali, A., Abbasi, K., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05797519

Clinical Safety and Efficacy of the VDyne Transcatheter ... The purpose of this clinical study is to collect safety and efficacy data of the VDyne System to support Conformitè Europëenne (CE) Mark of the VDyne System ...

2. mayo.edu mayo.edu/research/clinical-trials/cls-20545467

Clinical Safety and Efficacy of the VDyne Transcatheter ... The purpose of this early feasibility study (EFS) is to evaluate the safety and clinical performance of the VDyne System in the treatment of symptomatic severe ...

3. eurointervention.pcronline.com eurointervention.pcronline.com/article/first-in-human-description-of-a-novel-transcatheter-tricuspid-valve-prosthesis-to-preserve-the-asymmetric-shape-of-the-right-ventricle

First-in-human description of a novel transcatheter tricuspid ... A novel transcatheter tricuspid valve replacement prosthesis, the VDyne Valve, was successfully implanted in 3 patients with severe tricuspid regurgitation ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12040945/

Transcatheter tricuspid valve replacement: will it prevail? Transcatheter tricuspid valve replacement (TTVR) has rapidly emerged as a promising alternative, offering the potential for more effective treatment outcomes.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05848284

NCT05848284 | Clinical Safety and Efficacy of the VDyne ... The purpose of this clinical study is to evaluate the safety and clinical efficacy of the VDyne System in the treatment of symptomatic severe tricuspid ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10587843/

First-in-human description of a novel transcatheter tricuspid ... Transcatheter tricuspid valve replacement (TTVR) may provide a safe means of complete relief of tricuspid regurgitation (TR).

7. imrpress.com imrpress.com/journal/RCM/26/1/10.31083/RCM25712/htm

Transcatheter Tricuspid Valve Replacement - IMR Press The main issues related to TTVR are represented by the lack of long-term data regarding the durability of the valve, the risk of thrombosis and ...