AzTrials
AzTrials

Tricuspid RegurgitationVISTA-USNCT05848284

Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation ( VISTA-US)

A study testing VDyne Transcatheter Tricuspid Valve Replacement System in people with Tricuspid Regurgitation and Tricuspid Valve Disease, run by VDyne, Inc. at 11 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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 regurgitation (TR). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
VDyne Transcatheter Tricuspid Valve Replacement System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
11 sitesin 2 countries
Study dates
1 Apr 2024to 30 Nov 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Symptomatic severe tricuspid valve regurgitation of primary or secondary etiology.
  • NYHA class ≥ II. If NYHA Class IV, patient must be ambulatory.
  • Subject is adequately treated with medical therapy for heart failure ≥ 30 days prior to
  • index procedure, including a diuretic.
  • Heart Team determines patient is a recommended candidate for the VDyne System.
  • Age >18 years at time of index procedure.
  • Clinical Screening Committee (CSC) and Imaging Core Labs confirm suitability for treatment with the VDyne System.

Who cannot join

  • Patient anatomy (cardiac and vascular) is not suitable for VDyne System as assessed by Imaging Core Labs, Sponsor or Clinical Screening Committee (CSC)
  • Intolerance to procedural anticoagulation or post-procedural antiplatelet/ anticoagulation regimen that cannot be medically managed
  • Hypersensitivity to nickel or titanium
  • Left Ventricular Ejection Fraction (LVEF) <30%.
  • Severe RV dysfunction.
  • Significant abnormalities of the tricuspid valve and sub-valvular apparatus.
Show all 39Show fewer
  • Sepsis including active infective endocarditis (IE) (within last 6 months).
  • Right ventricular, atrial thrombus, vegetation or mass on tricuspid valve.
  • Severe tricuspid annular or leaflets calcification.
  • Systolic pulmonary hypertension with systolic pulmonary artery pressure >70 mmHg.
  • History or rheumatic fever
  • Significant coronary artery disease requiring treatment such as symptomatic, unresolved multi-vessel or unprotected left main coronary artery disease.
  • Any planned surgery or interventional procedure within 30 days prior to or 30 days following the implant procedure. This includes any planned concomitant cardiovascular procedure such as CABG, PCI, pulmonary vein ablation, left atrial appendage occlusion, septal defect repair, etc.
  • Unresolved severe symptomatic carotid stenosis (> 70% by ultrasound).
  • Cardiac resynchronization therapy device or implantable pulse generator implanted within 60 days of planned implant procedure.
  • Permanent pacing leads that will interfere with delivery or implantation of the VDyne Valve.
  • Cardiogenic shock or hemodynamic instability requiring inotropes or mechanical support devices at the time of planned implant procedure.
  • Prior tricuspid valve surgery or catheter-based therapy with permanent residual device(s) implanted that would preclude delivery or implantation of the VDyne Valve (e.g. valve replacement, edge to edge repair, etc.).
  • Significant valvular heart disease requiring intervention other than the tricuspid valve.
  • Known significant intracardiac shunt (e.g. septal defect)
  • Cerebrovascular accident (stroke, TIA) within 6 months of treatment procedure.
  • Severe lung disease (severe COPD or continuous use of home oxygen or oral steroids).
  • Acute myocardial infarction (AMI) within 30 days.
  • Significant renal dysfunction (eGFR<30 ml/min/1.73m2) or on dialysis.
  • End-stage liver disease (MELD > 11 / CHILD class C).
  • Bleeding requiring transfusion within prior 30 days.
  • Coagulopathy or other clotting disorder that cannot be medically managed.
  • Chronic immunosuppression or other condition that could impair healing response.
  • Any of the following: leukopenia, chronic anemia (Hgb < 9), thrombocytopenia, history of bleeding diathesis, or coagulopathy.
  • Unwilling to receive blood products.
  • Known hypersensitivity or contraindication to procedural or post-procedural medications (e.g., contrast solution) which cannot be adequately managed medically.
  • Life expectancy less than 12 months due to non-cardiac comorbidities.
  • Treatment is not expected to provide benefit (futile).
  • Current IV Drug user (must be free drug abuse for > 1 year).
  • Pregnant, lactating or planning pregnancy within next 12 months.
  • Vulnerable patient groups (minors, cognitively impaired persons, prisoners, persons whose willingness to volunteer could be unduly influenced by the expectation of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate, such as students, residents, and employees).
  • Currently participating in an investigational drug or device trial that has not reached its primary endpoint or is likely to interfere with this study.
  • Patient (or legal guardian) unable or unwilling to provide written, informed consent before study enrollment.
  • Patient unable or unwilling to comply with study required testing and follow-up visits

Trial locations and contacts

11 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Vinny Podichetty contact

763-777-5969

vpodichetty@vdyne.com

Jeya Satheesh contact

952-686-8158

jsatheesh@vdyne.com

11 sites in 2 countries

United States10 sites, 8 recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Natalie Drain, MHA, 843-876-5037, drain@musc.edu

    Nick Amoroso, MD

    Recruiting

  • The Christ Hospital

    Cincinnati, Ohio, 45219

    Belinda Frakes, 5135851777, Belinda.frakes@thechristhospital.com

    Santiago Garcia

    Recruiting

  • Henry Ford Hospital

    Detriot, Michigan, 48208

    Active, not recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

    Mitch Gheorghiu, 3104236152, Mitch.Gheorghiu@cshs.org

    Raj Makkar

    Recruiting

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407

    Active, not recruiting

  • Ascension St. Thomas

    Nashville, Tennessee, 37205

    Erin Beller, BSN, RN, 6152226997, erin.beller@ascension.org

    Andrew Morse, MD

    Recruiting

  • Columbia University Medical Center/NYPH

    New York, New York, 10032

    Treena Williams, 2123423485, taw2112@cumc.columbia.edu

    Torsten Vahl, MD

    Recruiting

  • Oregon Health and Science Unversity

    Portland, Oregon, 97239

    Anna Garwood, 503-494-3472, garwood@ohsu.edu

    Firas Zahr, MD

    Recruiting

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905

    Adam Logeman, 507-422-2263, Logeman.Adam@mayo.edu

    Recruiting

  • Montefiore Medical Center

    The Bronx, New York, 10467

    Kara Booth, (718) 920-6523, kbooth@montefiore.org

    Edwin Ho, MD

    Recruiting

Other trials in United States

Canada1 site, 1 recruiting

  • Québec-Université Laval (IUCPQ-ULaval)

    Québec, Quebec, G1V 4G5

    Dominique Lachance Clinical Study Coordinator, (418) 656-8711 ext. 3055, Dominique.Lachance@criucpq.ulaval.ca

    Joseph Rodés, MD

    Recruiting

Other trials in Canada

About this study

Official title: Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation

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 regurgitation (TR).

Being tested
VDyne Transcatheter Tricuspid Valve Replacement System
Keywords
VDyne
Medical subject headings
Tricuspid Valve Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VDyne Transcatheter Tricuspid Valve Replacement SystemDevice

    Also called VDyne System, VDyne Tricuspid System, VDyne Valve System, VDyne Valve

    The study investigational device is the VDyne Transcatheter Tricuspid Valve Replacement System which consists of a bioprosthetic implantable tricuspid valve, the VDyne Delivery System, Drop Tether, accessories that facilitate the placement of the valve and the VDyne Retrieval System. The VDyne Valve is deployed by transfemoral implantation within the native tricuspid valve and is implanted under fluoroscopic and transesophageal echocardiography (TEE) guidance, while the heart remains beating, without the use of CPB. The valve is repositionable and fully retrievable intraoperatively. Repositioning allows optimization of the valve position following deployment, and retrieval, with the VDyne Retrieval System, allows use of an alternative valve size or removal of the index VDyne Valve in the event of suboptimal valve delivery or other intraoperative complication.

Study groups in NCT05848284
Study groupRoleWhat they receive
VDyne System Treatment ArmExperimentalDevice
Receives: Device: VDyne Transcatheter Tricuspid Valve Replacement System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    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).

    Measured: Implant to 30 days post-procedure

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

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

    Measured: Baseline to 1 month after implant

  3. Changes in symptom status (NYHA class)

    Changes in symptom status (NYHA class)

    Measured: Baseline to 1 month after implant

  4. Changes in functional capacity (6-minute walk test)

    Changes in functional capacity (6-minute walk test)

    Measured: Baseline to 1 month after implant

  5. Changes in in quality of life (KCCQ score)

    Changes in in quality of life (KCCQ score). A higher score indicates worsening quality of life outcomes

    Measured: Baseline to 1 month after implant

Secondary outcomes (7)

  1. The percentage of subjects with Device- and/or Procedure-related Major Adverse Events (MAE) after 30 days to 1 year of the procedure, as classified by the Clinical Events Committee (CEC).

    The percentage of subjects with Device- and/or Procedure-related Major Adverse Events (MAE) after 30 days to 1 year of the procedure, as classified by the Clinical Events Committee (CEC).

    Measured: 30 days post-procedure to 1 year

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

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

    Measured: 1 month after implant to 1 year post-implant

  3. Changes in right ventricle as measured by core lab

    Changes in the right ventricle as measured by core lab

    Measured: 1 month after implant to 1 year post-implant

  4. Rate of heart failure hospitalization

    Rate of heart failure hospitalization

    Measured: 1 month after implant to 1 year post-implant

  5. Changes in symptom status (NYHA class)

    Changes in symptom status (NYHA class)

    Measured: 1 month after implant to 1 year post-implant

  6. Changes in functional capacity (6-minute walk test)

    Changes in functional capacity (6-minute walk test)

    Measured: 1 month after implant to 1 year post-implant

  7. Changes in in quality of life (KCCQ score).

    Changes in in quality of life (KCCQ score). A higher score indicates worsening outcomes

    Measured: 1 month after implant to 1 year post-implant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2023
  2. Study start1 Apr 2024
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion30 Nov 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05848284
Sponsor's protocol ID
TPR0037-P
Acronym
VISTA-US
Status last verified
Sep 2026
First submitted
29 Mar 2023
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing VDyne Transcatheter Tricuspid Valve Replacement System in people with Tricuspid Regurgitation and Tricuspid Valve Disease, run by VDyne, Inc. at 11 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Vinny Podichetty (763-777-5969, vpodichetty@vdyne.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). (time frame: Implant to 30 days post-procedure). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05848284.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in