search
Back to results

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

Primary Purpose

Tricuspid Regurgitation, Tricuspid Valve Disease, Tricuspid Valvular Disorders

Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
VDyne Transcatheter Tricuspid Valve Replacement System
Sponsored by
VDyne, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tricuspid Regurgitation focused on measuring VDyne

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic - Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

VDyne System Treatment Arm

Arm Description

Device

Outcomes

Primary Outcome Measures

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).
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
Changes in symptom status (NYHA class)
Changes in symptom status (NYHA class)
Changes in functional capacity (6-minute walk test)
Changes in functional capacity (6-minute walk test)
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

Secondary Outcome Measures

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).
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
Changes in right ventricle as measured by core lab
Changes in the right ventricle as measured by core lab
Rate of heart failure hospitalization
Rate of heart failure hospitalization
Changes in symptom status (NYHA class)
Changes in symptom status (NYHA class)
Changes in functional capacity (6-minute walk test)
Changes in functional capacity (6-minute walk test)
Changes in in quality of life (KCCQ score).
Changes in in quality of life (KCCQ score). A higher score indicates worsening outcomes

Full Information

First Posted
March 29, 2023
Last Updated
April 27, 2023
Sponsor
VDyne, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT05848284
Brief Title
Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation ( VISTA-US)
Acronym
VISTA-US
Official Title
Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 30, 2023 (Anticipated)
Primary Completion Date
November 30, 2025 (Anticipated)
Study Completion Date
November 30, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VDyne, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tricuspid Regurgitation, Tricuspid Valve Disease, Tricuspid Valvular Disorders
Keywords
VDyne

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VDyne System Treatment Arm
Arm Type
Experimental
Arm Description
Device
Intervention Type
Device
Intervention Name(s)
VDyne Transcatheter Tricuspid Valve Replacement System
Other Intervention Name(s)
VDyne System, VDyne Tricuspid System, VDyne Valve System, VDyne Valve
Intervention Description
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 Information:
Title
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).
Description
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
Title
Change in tricuspid valve regurgitation compared to baseline as measured by the Imaging Core Labs
Description
Change in tricuspid valve regurgitation compared to baseline as measured by the Imaging Core Labs
Time Frame
Baseline to 1 month after implant
Title
Changes in symptom status (NYHA class)
Description
Changes in symptom status (NYHA class)
Time Frame
Baseline to 1 month after implant
Title
Changes in functional capacity (6-minute walk test)
Description
Changes in functional capacity (6-minute walk test)
Time Frame
Baseline to 1 month after implant
Title
Changes in in quality of life (KCCQ score)
Description
Changes in in quality of life (KCCQ score). A higher score indicates worsening quality of life outcomes
Time Frame
Baseline to 1 month after implant
Secondary Outcome Measure Information:
Title
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).
Description
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).
Time Frame
30 days post-procedure to 1 year
Title
Change in tricuspid valve regurgitation compared to baseline as measured by the Imaging Core Labs
Description
Change in tricuspid valve regurgitation compared to baseline as measured by the Imaging Core Labs
Time Frame
1 month after implant to 1 year post-implant
Title
Changes in right ventricle as measured by core lab
Description
Changes in the right ventricle as measured by core lab
Time Frame
1 month after implant to 1 year post-implant
Title
Rate of heart failure hospitalization
Description
Rate of heart failure hospitalization
Time Frame
1 month after implant to 1 year post-implant
Title
Changes in symptom status (NYHA class)
Description
Changes in symptom status (NYHA class)
Time Frame
1 month after implant to 1 year post-implant
Title
Changes in functional capacity (6-minute walk test)
Description
Changes in functional capacity (6-minute walk test)
Time Frame
1 month after implant to 1 year post-implant
Title
Changes in in quality of life (KCCQ score).
Description
Changes in in quality of life (KCCQ score). A higher score indicates worsening outcomes
Time Frame
1 month after implant to 1 year post-implant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pree Bassi
Phone
6124386888
Email
pbassi@vdyne.com
Facility Information:
Facility Name
Mayo Clinic - Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Logeman
Phone
507-422-2263
Email
Logeman.Adam@mayo.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.vdyne.com
Description
Related Info

Learn more about this trial

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

We'll reach out to this number within 24 hrs