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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Tricuspid Regurgitation; Tricuspid Valve Disease; Tricuspid Valvular Disorders
• Intervention / Treatment: Device: VDyne Transcatheter Tricuspid Valve Replacement System

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Pree Bassi; Phone Number: 6124386888; Email: pbassi@vdyne.com

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic - Rochester
      • Contact: Adam Logeman; Phone Number: 507-422-2263; Email: Logeman.Adam@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 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.
• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: VDyne System Treatment Arm; Device

Device: 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.; Other Names: VDyne System; VDyne Tricuspid System; VDyne Valve System; VDyne Valve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Implant to 30 days post-procedure
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	Baseline to 1 month after implant
Changes in symptom status (NYHA class)	Changes in symptom status (NYHA class)	Baseline to 1 month after implant
Changes in functional capacity (6-minute walk test)	Changes in functional capacity (6-minute walk test)	Baseline to 1 month after implant
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	Baseline to 1 month after implant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	30 days post-procedure to 1 year
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	1 month after implant to 1 year post-implant
Changes in right ventricle as measured by core lab	Changes in the right ventricle as measured by core lab	1 month after implant to 1 year post-implant
Rate of heart failure hospitalization	Rate of heart failure hospitalization	1 month after implant to 1 year post-implant
Changes in symptom status (NYHA class)	Changes in symptom status (NYHA class)	1 month after implant to 1 year post-implant
Changes in functional capacity (6-minute walk test)	Changes in functional capacity (6-minute walk test)	1 month after implant to 1 year post-implant
Changes in in quality of life (KCCQ score).	Changes in in quality of life (KCCQ score). A higher score indicates worsening outcomes	1 month after implant to 1 year post-implant

Collaborators and Investigators

• Sponsor: VDyne, Inc.

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Anticipated): May 30, 2023
• Primary Completion (Anticipated): November 30, 2025
• Study Completion (Anticipated): November 30, 2030

Study Registration Dates

• First Submitted: March 29, 2023
• First Submitted That Met QC Criteria: April 27, 2023
• First Posted (Actual): May 8, 2023

Study Record Updates

• Last Update Posted (Actual): May 8, 2023
• Last Update Submitted That Met QC Criteria: April 27, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: VDyne
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID Numbers: TPR0037-P

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes