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Transcatheter Valve Replacement
VDyne Valve Replacement for Tricuspid Regurgitation (VISTA-US Trial)
Phase 1
Waitlist Available
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month after implant to 1 year post-implant
Awards & highlights
VISTA-US Trial Summary
This trial tests a new device to treat severe TR, a heart valve disorder. It will assess safety & effectiveness.
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.Check my eligibility
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.See study design
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.
VISTA-US Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
VISTA-US Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 moreVISTA-US Trial Design
1Treatment groups
Experimental Treatment
Group I: VDyne System Treatment ArmExperimental Treatment1 Intervention
Device
Find a Location
Who is running the clinical trial?
VDyne, Inc.Lead Sponsor
1 Previous Clinical Trials
40 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe narrowing in my neck arteries causing symptoms.I have severe symptoms from a faulty heart valve.I have a low white blood cell count, chronic anemia, low platelet count, or a history of bleeding disorders.I am older than 18 years.I have not had a stroke or mini-stroke in the last 6 months.You cannot be currently using intravenous drugs, and must have been free from drug abuse for more than one year.I had a heart device implanted within the last 60 days.My heart's pumping ability is severely reduced.My liver is in a very advanced stage of disease.I have a condition that affects my body's ability to heal.I have a significant heart defect, like a hole in the heart.I have not had a heart attack in the last 30 days.You have a pacemaker that might get in the way of putting in the VDyne Valve.I have a blood clotting disorder that cannot be controlled with medication.I am allergic or react badly to certain medications used during or after procedures.My kidney function is very low or I am on dialysis.My doctor does not expect my treatment to work.I am not willing to receive blood transfusions.My heart condition affects my daily activities but I can still walk.Your heart and blood vessels are not suitable for the VDyne System, as determined by specialized medical imaging or a committee of doctors.I have not needed a blood transfusion for bleeding in the last 30 days.I cannot or do not want to give consent for the study.I have severe lung disease or need constant oxygen or steroids.I have a serious issue with my tricuspid heart valve.Your blood pressure in the arteries leading to your lungs is very high.I have a serious heart valve problem that needs treatment, but it's not the tricuspid valve.I am unable or unwilling to follow the study's required tests and visits.You have a blood clot or growth in the right side of your heart or on the tricuspid valve.I have not had sepsis or active infective endocarditis in the last 6 months.I have severe hardening of my heart's tricuspid valve.I have no surgeries planned 30 days before or after the implant procedure.I have serious heart artery problems needing treatment.I need drugs or devices to help my heart pump during my planned procedure.I cannot tolerate blood thinners due to side effects that can't be managed.You have other health problems that may make you likely to live less than a year.You are allergic to nickel or titanium.My heart's right ventricle is not working well.I have had previous heart valve surgery or treatment that prevents me from getting the VDyne Valve.I have been on heart failure medication, including a diuretic, for at least 30 days.
Research Study Groups:
This trial has the following groups:- Group 1: VDyne System Treatment Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there potential risks associated with the VDyne System Treatment Arm?
"The VDyne System Treatment Arm is a Phase 1 trial and thus has limited evidence for both safety and efficacy, so it was rated as a 1 on our scale."
Answered by AI
Are there currently any vacancies within this research trial?
"Accoridng to the clinicaltrials.gov website, this research trial is not actively recruiting patients at present. Originally posted on May 30th 2023 and last updated April 27th 2023, it does not seek participants presently - but there are 49 other trials that do require volunteers now."
Answered by AI
What is the ambition of this experiment?
"According to the study sponsor, VDyne Inc., this trial aims to measure Changes in quality of life (KCCQ score) over a period ranging from Implantation up until 30 days after. It will also evaluate secondary objectives such as changes in symptom status (NYHA class), functional capacity (6-minute walk test), and percentage of Device- or Procedure-related Major Adverse Events (MAE) within 1 year monitored by the Clinical Events Committee."
Answered by AI
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