VDyne Valve Replacement for Tricuspid Regurgitation
(VISTA-US Trial)
Recruiting in Palo Alto (17 mi)
+8 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: VDyne, Inc.
Must be taking: Diuretics
Disqualifiers: Severe COPD, Severe RV dysfunction, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
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 data supports the effectiveness of the VDyne Transcatheter Tricuspid Valve Replacement System treatment for tricuspid regurgitation?
Research shows that transcatheter tricuspid valve replacement is a feasible option for high-risk patients with valve degeneration, providing an alternative to traditional surgery. Studies have demonstrated its use in similar procedures, like valve-in-valve replacements, indicating potential effectiveness for patients with tricuspid regurgitation.
12345Is the VDyne Valve Replacement generally safe for humans?
The VDyne Valve Replacement, used for tricuspid regurgitation, has been tested in a small group of patients and is part of a broader category of transcatheter valve replacements, which have shown comparable safety to surgical options in some studies. However, detailed long-term safety data specific to the VDyne Valve is limited.
16789How is the VDyne Valve Replacement treatment different from other treatments for tricuspid regurgitation?
The VDyne Valve Replacement is unique because it is a transcatheter procedure, meaning it is done through a small tube inserted into a blood vessel, which is less invasive than traditional surgery. This approach is particularly beneficial for high-risk patients who may not be suitable for conventional surgery, and it offers a promising alternative when repair of the valve is not possible or effective.
34101112Eligibility Criteria
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
+3 more
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
+35 more
Trial Timeline
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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: VDyne System Treatment ArmExperimental Treatment1 Intervention
Device
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Minneapolis Heart Institute FoundationMinneapolis, MN
Henry Ford HospitalDetriot, MI
Montefiore Medical CenterBronx, NY
Medical University of South CarolinaCharleston, SC
More Trial Locations
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Who Is Running the Clinical Trial?
VDyne, Inc.Lead Sponsor
References
Long-term follow-up after trans-catheter tricuspid valve-in-valve replacement with balloon-expandable aortic valves. [2017]Transcatheter tricuspid VIV replacement has been proposed as a feasible option for high-risk patients with previous tricuspid valve replacement that undergo valve degeneration causing refractory heart failure. However, little is known about the long-term outcome of patients treated with transcatheter tricuspid VIV. We evaluate the safety of transcatheter tricuspid valve-in-valve (VIV) replacement by using balloon-expandable aortic valve stents and the long-term follow-up.
Effect of Concomitant Tricuspid Valve Surgery With Left Ventricular Assist Device Implantation. [2021]Tricuspid regurgitation (TR) is common in advanced heart failure (HF) patients. However, the effect of concomitant tricuspid valve repair or replacement (tricuspid valve intervention [TVI]) with left ventricular assist device (LVAD) implantation is controversial. The aim of this study was to investigate the longitudinal trend of TR after LVAD implantation and the effect of TVI on the TR trend and clinical outcomes.
Tough Crossing: A Challenging Case of Valve-in-Valve Transcatheter Tricuspid Valve Replacement. [2023]Transcatheter tricuspid valve replacement is a feasible treatment alternative in high-risk patients with degenerated tricuspid prosthesis. Either transjugular or transfemoral approaches are feasible, with the latter being used more commonly. We describe a challenging case of valve-in-valve transcatheter tricuspid valve replacement where we used a long sheath positioned in the right ventricular outflow tract to deliver the transcatheter heart valve.
Tricuspid valve replacement with a bioprosthetic valve. [2016]Significant tricuspid regurgitation (TR) is present in many patients with heart failure. Valve replacement is necessary in patients in whom the valve is irreparable or in whom there is a high risk of late failure. The following manuscript and videos describe our approach to tricuspid valve replacement with a bioprosthetic valve.
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. [2023]Transcatheter tricuspid valve-in-valve (TTViV) replacement has become an alternative treatment in high-risk patients with bioprosthetic valve degeneration. This is the first report on the mid to long-term echocardiographic findings of patients who underwent TTViV replacement in a cardiac referral center in Iran.
Transcatheter Valve Replacement for Right-sided Valve Disease in Congenital Heart Patients. [2018]Pulmonary and/or tricuspid valve dysfunction is common among individuals with congenital heart disease, and surgical intervention often carries prohibitive risks. Transcatheter valve replacement (TVR) of the right-sided cardiac valves has become a viable treatment option over the past two decades, while continued technological development aims to broaden its applicability to an even larger portion of those with repaired congenital heart disease. To date, two transcatheter valves have been approved for use in patients with dysfunctional right ventricular to pulmonary artery conduits as well as those with failing pulmonic bioprosthetic valves, and are also used off-label in the "native" RVOT and within surgically repaired/replaced but failing tricuspid valves. TVR has demonstrated comparable safety and short-term outcomes to that of surgical valve replacement. This article aims to review current available devices, focusing on their safety, efficacy and on and off label usage, while briefly describing some of the emerging devices and novel procedural techniques that will likely lead to significant expansion of transcatheter treatment of right sided valve disease in the future.
Early Single-Site Experience With Transcatheter Tricuspid Valve Replacement. [2020]This study presents a single-site experience of 5 patients with severe tricuspid regurgitation (TR) who underwent implantation of a novel transcatheter tricuspid valve replacement device.
Tricuspid valve replacement: an analysis of risk factors and outcomes. [2008]Tricuspid valve replacement (TVR) is rarely performed and is associated with a high morbidity and mortality. We report our experience with TVR and related adverse events.
Tricuspid valve replacement after cardiac transplantation. [2022]Tricuspid regurgitation (TR) occurs commonly in transplanted hearts. Although theoretically attractive, tricuspid valve replacement (TVR) has not been widely investigated as a possible therapy in post-transplant patients. The purpose of this study was to determine the safety of TVR in heart transplant patients and its effects on measurable clinical endpoints.
Bioprosthetic tricuspid valve replacement for tricuspid valve endocarditis secondary to infected endocardial pacemaker leads. [2017]The purpose of this study was to present outcomes of bioprosthetic tricuspid valve replacement (TVR) in patients with tricuspid valve infective endocarditis (TVIE).
Transcatheter tricuspid valve intervention: a practical algorithm for patient selection. [2020]Worldwide experience in transcatheter tricuspid valve intervention is increasing as more options become available for the treatment of severe tricuspid regurgitation. These devices can be categorized by their primary mechanism of action, including edge-to-edge leaflet devices, space occupying devices, annuloplasty devices, complete valve replacement and caval valve implantation. This review summarizes the current technologies in use, early clinical results and factors that may affect procedural success.
Update on Transcatheter Tricuspid Valve Replacement Therapies. [2021]Severe tricuspid regurgitation is relatively common, especially in the elderly, and portends poor survival. Neither medical therapy nor conventional surgery is efficacious for most patients. In contrast, transcatheter tricuspid valve interventions are showing promise to improve quality of life and mortality. Although there is more clinical experience with transcatheter tricuspid valve repair, there are many patients for which repair is either not possible or cannot optimally reduce the severity of tricuspid regurgitation. Transcatheter tricuspid valve replacement is rapidly emerging and may ultimately become the preferred treatment option. In this review, we discuss transcatheter tricuspid valve replacement, analyze the devices in development and in clinical trials, and highlight the advantages and drawbacks of transcatheter tricuspid valve replacement vs. repair.