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

Primary Purpose

Tricuspid Regurgitation, Tricuspid Valve Disease, Tricuspid Valvular Disorders

Status
Recruiting
Phase
Phase 1
Locations
International
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

Eligibility Criteria

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

Inclusion Criteria: Moderate or severe tricuspid valve regurgitation of primary or secondary etiology. 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 or older. Clinical Screening Committee (CSC) and Imaging Core Labs confirm suitability for treatment with the VDyne System. Exclusion Criteria: VDYNE SYSTEM SUITABILITY Patient anatomy (cardiac and vascular) is not suitable for the VDyne System as assessed by Imaging Core Labs Intolerance to procedural anticoagulation or post-procedural antiplatelet/anticoagulation regimen that cannot be medically managed Hypersensitivity to nickel or titanium CLINICAL EXCLUSION CRITERIA (assessed by pre-procedural imaging) 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 or atrial thrombus or vegetation Severe tricuspid annular or leaflets calcification Systolic pulmonary hypertension with systolic pulmonary artery pressure ≥70 mmHg. CONCOMITANT PROCEDURES 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 the period of 30 days prior to 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 devices implanted that would preclude delivery or implantation of the VDyne Valve (e.g. valve replacement, edge to edge repair.) Severe valvular heart disease requiring intervention other than the tricuspid valve Known significant intracardiac shunt (e.g. septal defect) (PFO's without significant shunts are allowed) COMORBIDITIES 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 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 GENERAL EXCLUSION CRITERIA 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. (Female of child-bearing potential use two reliable contraceptive methods during the study - hormonal methods such as pill and condom). 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-specific procedures are conducted Patient unable or unwilling to comply with study required testing and follow-up visits.

Sites / Locations

  • St. Vincent HospitalRecruiting
  • Monash HeartRecruiting
  • Na Homolce HospitalRecruiting
  • Nemocnice AGEL Podlesi TrinecRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

VDyne System Treatment Arm

Arm Description

Outcomes

Primary Outcome Measures

The percentage of subjects with Device- and/or Procedure-related Major Adverse Events (MAE)
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).
Mortality
Mortality will be reported at 30 days post-procedure
Device success
Rate of successful implantation of the VDyne Valve using the VDyne Delivery System
Procedural success
Rate of successful implantation of the VDyne Valve using the VDyne Delivery System & freedom from serious device and/or procedure-related adverse events
Change in tricuspid valve regurgitation as measured by the Imaging Core Labs
Change in tricuspid valve regurgitation as measured by the Imaging Core Labs
Changes in quality of life as measured by the KCCQ changes.
Changes in quality of life as measured by the KCCQ changes. Higher score indicates worse outcome.
Changes in functional capacity (6-minute walk test)
Changes in functional capacity (6-minute walk test)
Changes in symptom status (NYHA class)
Changes in symptom status (NYHA class)

Secondary Outcome Measures

The percentage of subjects with Device- and/or Procedure-related Major Adverse Events (MAE)
The percentage of subjects with Device- and/or Procedure related Major Adverse Events as classified by the CEC
Change in tricuspid valve regurgitation as measured by the Imaging Core Lab
Change in tricuspid valve regurgitation as measured by the Imaging 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 quality of life as measured by the KCCQ changes.
Changes in quality of life as measured by the KCCQ changes. Higher score indicates worse outcome.

Full Information

First Posted
March 6, 2023
Last Updated
April 5, 2023
Sponsor
VDyne, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05797519
Brief Title
Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation
Acronym
VISTA
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
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
September 30, 2029 (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
Product Manufactured in and Exported from the U.S.
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 moderate to 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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
VDyne System Treatment Arm
Arm Type
Experimental
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)
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
30 days post-procedure
Title
Mortality
Description
Mortality will be reported at 30 days post-procedure
Time Frame
30 days post-procedure
Title
Device success
Description
Rate of successful implantation of the VDyne Valve using the VDyne Delivery System
Time Frame
From implant start time to procedure room exit
Title
Procedural success
Description
Rate of successful implantation of the VDyne Valve using the VDyne Delivery System & freedom from serious device and/or procedure-related adverse events
Time Frame
From implant start time to procedure room exit
Title
Change in tricuspid valve regurgitation as measured by the Imaging Core Labs
Description
Change in tricuspid valve regurgitation as measured by the Imaging Core Labs
Time Frame
From Baseline to 1 month post-procedure
Title
Changes in quality of life as measured by the KCCQ changes.
Description
Changes in quality of life as measured by the KCCQ changes. Higher score indicates worse outcome.
Time Frame
From Baseline to 1 month post-procedure
Title
Changes in functional capacity (6-minute walk test)
Description
Changes in functional capacity (6-minute walk test)
Time Frame
From Baseline to 1 month post-procedure
Title
Changes in symptom status (NYHA class)
Description
Changes in symptom status (NYHA class)
Time Frame
From Baseline to 1 month post-procedure
Secondary Outcome Measure Information:
Title
The percentage of subjects with Device- and/or Procedure-related Major Adverse Events (MAE)
Description
The percentage of subjects with Device- and/or Procedure related Major Adverse Events as classified by the CEC
Time Frame
From Baseline to 1 year post-procedure
Title
Change in tricuspid valve regurgitation as measured by the Imaging Core Lab
Description
Change in tricuspid valve regurgitation as measured by the Imaging Core Lab
Time Frame
From Baseline to 3 months, 6 months and 1 year
Title
Rate of heart failure hospitalization
Description
Rate of heart failure hospitalization
Time Frame
From Baseline to 3 months, 6 months and 1 year
Title
Changes in symptom status (NYHA class)
Description
Changes in symptom status (NYHA class)
Time Frame
From Baseline to 3 months, 6 months and 1 year
Title
Changes in functional capacity (6 minute walk test)
Description
Changes in functional capacity (6 minute walk test)
Time Frame
From Baseline to 3 months, 6 months and 1 year
Title
Changes in quality of life as measured by the KCCQ changes.
Description
Changes in quality of life as measured by the KCCQ changes. Higher score indicates worse outcome.
Time Frame
From Baseline to 3 months, 6 months and 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Moderate or severe tricuspid valve regurgitation of primary or secondary etiology. 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 or older. Clinical Screening Committee (CSC) and Imaging Core Labs confirm suitability for treatment with the VDyne System. Exclusion Criteria: VDYNE SYSTEM SUITABILITY Patient anatomy (cardiac and vascular) is not suitable for the VDyne System as assessed by Imaging Core Labs Intolerance to procedural anticoagulation or post-procedural antiplatelet/anticoagulation regimen that cannot be medically managed Hypersensitivity to nickel or titanium CLINICAL EXCLUSION CRITERIA (assessed by pre-procedural imaging) 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 or atrial thrombus or vegetation Severe tricuspid annular or leaflets calcification Systolic pulmonary hypertension with systolic pulmonary artery pressure ≥70 mmHg. CONCOMITANT PROCEDURES 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 the period of 30 days prior to 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 devices implanted that would preclude delivery or implantation of the VDyne Valve (e.g. valve replacement, edge to edge repair.) Severe valvular heart disease requiring intervention other than the tricuspid valve Known significant intracardiac shunt (e.g. septal defect) (PFO's without significant shunts are allowed) COMORBIDITIES 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 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 GENERAL EXCLUSION CRITERIA 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. (Female of child-bearing potential use two reliable contraceptive methods during the study - hormonal methods such as pill and condom). 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-specific procedures are conducted 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
Laura Moffett
Phone
+1.952.303.2821
Email
lmoffett@vdyne.com
First Name & Middle Initial & Last Name or Official Title & Degree
Pree Bassi
Phone
+1-612-438-6888
Email
pbassi@vdyne.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Moffett
Organizational Affiliation
VDyne, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
St. Vincent Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erika O'Dea
Phone
+61 2 8382 2775
Email
Erika.odea@svha.org.au
Facility Name
Monash Heart
City
Melbourne
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra Jackson
Email
Alexandra.Jackson@monashhealth.org
Facility Name
Na Homolce Hospital
City
Prague
ZIP/Postal Code
15030
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petr Moucka, Mgr.
Phone
+420 257 272 392
Email
Petr.Moucka@homolka.cz
Facility Name
Nemocnice AGEL Podlesi Trinec
City
Trinec
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miroslav Hudec
Email
miro.hudy@seznam.cz

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make IPD available.

Learn more about this trial

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

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