Recruiting

VDyne

Sponsor:

VDyne, Inc.

Code:

NCT05848284

Conditions

Tricuspid Regurgitation

Tricuspid Valve Disease

Tricuspid Valvular Disorders

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

VDyne Transcatheter Tricuspid Valve Replacement System

Study Details

Brief 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).

Conditions

Tricuspid Regurgitation

Tricuspid Valve Disease

Tricuspid Valvular Disorders

Study ID

NCT05848284

Start date

Apr 1, 2024

Status verified date

Feb, 2026

Completion date

Nov 30, 2031

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: VDyne System Treatment Arm

Device

Interventions

VDyne Transcatheter Tricuspid Valve Replacement System

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.

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 ]
  • Change in tricuspid valve regurgitation compared to baseline as measured by the Imaging Core Labs [ Time Frame: Baseline to 1 month after implant ]
  • Changes in symptom status (NYHA class) [ Time Frame: Baseline to 1 month after implant ]
  • Changes in functional capacity (6-minute walk test) [ Time Frame: Baseline to 1 month after implant ]
  • Changes in in quality of life (KCCQ score) [ Time Frame: Baseline to 1 month after implant ]

Central Contacts and Locations

Central contacts

Vinny Podichetty

763-777-5969vpodichetty@vdyne.com

Jeya Satheesh

952-686-8158jsatheesh@vdyne.com

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Mitch Gheorghiu

3104236152Mitch.Gheorghiu@cshs.org

Principal Investigator:

Raj Makkar

Henry Ford Hospital

Recruiting

Detriot, Michigan, United States, 48208

Contacts

Sahar Razmjou

313.916.4475srazmjo1@hfhs.org

Principal Investigator:

Brian O'Neill, MD

Minneapolis Heart Institute Foundation

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Jason Digman

(612) 863-9291Jason.Digman@allina.com

Principal Investigator:

Konstantinos Voudris

Mayo Clinic - Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Adam Logeman

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

Columbia University Medical Center/NYPH

Recruiting

New York, New York, United States, 10032

Contacts

Treena Williams

2123423485taw2112@cumc.columbia.edu

Principal Investigator:

Susheel Kodali, MD

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Contacts

Kara Booth

(718) 920-6523kbooth@montefiore.org

Principal Investigator:

Edwin Ho, MD

The Christ Hospital

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Belinda Frakes

5135851777Belinda.frakes@thechristhospital.com

Principal Investigator:

Santiago Garcia

Oregon Health and Science Unversity

Recruiting

Portland, Oregon, United States, 97239

Contacts

Anna Garwood

503-494-3472garwood@ohsu.edu

Principal Investigator:

Firas Zahr, MD

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Natalie Drain, MHA

843-876-5037drain@musc.edu

Principal Investigator:

Nick Amoroso, MD

Ascension St. Thomas

Recruiting

Nashville, Tennessee, United States, 37205

Contacts

Erin Beller, BSN, RN

6152226997erin.beller@ascension.org

Principal Investigator:

Andrew Morse, MD

Québec-Université Laval (IUCPQ-ULaval)

Recruiting

Québec, Quebec, Canada, G1V 4G5

Contacts

Dominique Lachance Clinical Study Coordinator

(418) 656-8711Dominique.Lachance@criucpq.ulaval.ca

Principal Investigator:

Joseph Rodés, MD

More Information

Sponsor

VDyne, Inc.

Last update posted

Mar 31, 2026

Last verified

Feb, 2026

Keywords

  • VDyne

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VDyne, Inc. on 2026-03-31.