Tricuspid RegurgitationVISTANCT05797519
Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation
A study testing VDyne Transcatheter Tricuspid Valve Replacement System in people with Tricuspid Regurgitation and Tricuspid Valve Disease, run by VDyne, Inc. at 21 sites in 11 countries.
Trial summary
The purpose of this clinical study is to collect safety and efficacy data of the VDyne System to support Conformitè Europëenne (CE) Mark of the VDyne System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Regurgitation, Tricuspid Valve Disease, Tricuspid Valvular Disorders
- 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
- 120 participants
- Where
- 21 sitesin 11 countries
- Study dates
- 1 Mar 2023to 30 Dec 2030
- 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
- Severe or greater 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 or older at time of the index procedure.
- Clinical Screening Committee (CSC) and Imaging Core Labs confirm suitability for treatment with the VDyne System.
Who cannot join
- VDYNE SYSTEM SUITABILITY
- Patient anatomy (cardiac and vascular) is not suitable for the VDyne System as assessed by Imaging Core Labs, Sponsor and/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
- CLINICAL EXCLUSION CRITERIA (assessed by pre-procedural imaging)
- Left Ventricular Ejection Fraction (LVEF) <30%
Show all 43Show fewer
- Severe RV dysfunction as assessed by the Clinical Screening Committee (CSC).
- Significant abnormalities of the tricuspid valve and sub-valvular apparatus
- Sepsis including active infective endocarditis (IE) (within the 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 or pulmonary vascular resistance (PVR) >5 wood units as determined by RHC.
- History of rheumatic fever that impacts the native tricuspid valve or surrounding structures.
- CONCOMITANT PROCEDURES
- Significant coronary artery disease requiring treatment such as symptomatic, unresolved multi-vessel or unprotected left main coronary artery disease (CAD).
- Any planned surgery or interventional procedure within 30 days prior to or following the implant procedure. This includes any planned concomitant cardiovascular procedure [e.g. Coronary Artery Bypass Grafting (CABG), percutaneous coronary intervention (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), patent foramen ovales (PFOs) without significant shunts are allowed]
- COMORBIDITIES
- Cerebrovascular accident (stroke, TIA) within 6 months of treatment procedure
- Severe lung disease [severe chronic obstructive pulmonary disease (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 and Child-Pugh 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 [Hemoglobin (Hgb) < 9], current thrombocytopenia (platelets <70), 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 during the course of the study
- 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.
Trial locations and contacts
21 sites in 11 countries. Contact the study team or a site near you to ask about taking part.
21 sites in 11 countries
Australia5 sites, 5 recruiting
- Recruiting
Flinders Medical Centre
Adelaide
Rhys Hamson, 08 8204 5382, Rhys.Hamson@sa.gov.au
Ajay Sinhal, MD
- Recruiting
Princess Alexandra Hospital
Brisbane
Cardiology PAH, CardResPAH@health.qld.gov.au
Anthony Camuglia, MD
- Recruiting
The Prince Charles Hospital
Brisbane
Maricel Roxas, 07 31395906, maricel.roxas@health.qld.gov.au
Darren Walters, MD
- Recruiting
Monash Heart
Melbourne
Emmy Ryal, emmanuela.ryal@monashhealth.org
- Recruiting
St. Vincent Hospital
Sydney, New South Wales, 2010
Erika O'Dea, +61 2 8382 2775, Erika.odea@svha.org.au
Germany4 sites, 4 recruiting
- Recruiting
Herz & Diabeteszentrum Nordrhein Westfalen
Bad Oeynhausen
Sabine Siegling, SSiegling@hdz-nrw.de
Volker Rudolph
- Recruiting
Vivantes Klinik Am Urban
Berlin, 10967
Hüseyin Ince, Prof. Dr. med., (030) 130 14 2011, hueseyin.ince@vivantes.de
- Recruiting
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, 24105
Andrea Koch, 0431-500-22917 ext. oder 22919, Andrea.Koch@uksh.de
- Recruiting
Universitätsmedizin Rostock
Rostock, 18057
Hüseyin Ince, Univ.- Prof. Dr. med., (030) 130 225101, Hueseyin.Ince@vivantes.de
Austria2 sites, 1 recruiting
- Recruiting
Johannes Kepler University Linz - JKU
Linz
Jörg Kellermair, MD, joerg_kellermair@hotmail.com
Andreas Zierer, MD
- Withdrawn
Universitätsklinik für Herzchirurgie Medizinische Universität Wien
Vienna, 1090
Spain2 sites, 1 recruiting
- Withdrawn
Hospital Universitario Puerta de Hierro
Madrid, 28222
- Recruiting
Hospital Clínico San Carlos
Madrid
Luis Nombela-Franco, MD, PhD, +34629510139, luisnombela@yahoo.com
María Aránzazu Pozzi Ortega, aranzazu.ortega@salud.madrid.org
United Kingdom2 sites, 1 recruiting
- Recruiting
Royal Sussex Hospital
Brighton, Sussex, BN2 1ES
Megan White, 01273 696955 ext. 64049, megan.white10@nhs.net
David Hildick-Smith
- Withdrawn
Royal Brompton Hospital
London
Belgium1 site, 1 recruiting
- Recruiting
AZ Sint Jan Hospital
Bruges
Katrien Derycker, Katrien.Derycker@azsintjan.be
Jan Van der Heyden
Czechia1 site, 1 recruiting
- Recruiting
Nemocnice AGEL Podlesi Trinec
Třinec
Miroslav Hudec, miro.hudy@seznam.cz
New Zealand1 site
- Active, not recruiting
Waikato Hospital
Hamilton, Hamilton, 3204
About this study
The purpose of this clinical study is to collect safety and efficacy data of the VDyne System to support Conformitè Europëenne (CE) Mark of the VDyne System.
- Being tested
- VDyne Transcatheter Tricuspid Valve Replacement System
- 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.
| Study group | Role | What they receive |
|---|---|---|
| VDyne System Treatment Arm | Experimental | Not described 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.
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).
Measured: 30 days post-procedure
Change in tricuspid valve regurgitation as measured by the Imaging Core Labs
Change in tricuspid valve regurgitation as measured by the Imaging Core Labs
Measured: From Baseline to 1 month post-procedure
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.
Measured: From Baseline to 1 month post-procedure
Changes in functional capacity (6-minute walk test)
Changes in functional capacity (6-minute walk test)
Measured: From Baseline to 1 month post-procedure
Changes in symptom status (NYHA class)
Changes in symptom status (NYHA class)
Measured: From Baseline to 1 month post-procedure
Secondary outcomes (9)
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
Measured: From Baseline to 1 year post-procedure
Change in tricuspid valve regurgitation as measured by the Imaging Core Lab
Change in tricuspid valve regurgitation as measured by the Imaging Core Lab
Measured: From Baseline to 3 months, 6 months and 1 year
Intra-Procedural success
Rate of successful implantation of the VDyne Valve using the VDyne Delivery System, absence of procedural mortality or stroke, adequate performance of the VDyne Valve, no device-related obstruction of forward flow or pulmonary embolism and \& freedom from emergency surgery or reintervention during the first 24 hours related to the device or access procedure.
Measured: From implant start time to procedure room exit
Clinical success
Absence of procedural mortality, proper position of the device with adequate performance, freedom from unplanned surgical or interventional procedures related to the device or procedure, absence of major adverse events, device related pulmonary embolism and obstruction of forward flow, any severe hemodynamic compromise leading to heart transplantation or major cardiac assistance or any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention.
Measured: From implant to 30 days post implant
Changes in symptom status (NYHA class)
Changes in symptom status (NYHA class)
Measured: From Baseline to 3 months, 6 months and 1 year
Changes in functional capacity (6 minute walk test)
Changes in functional capacity (6 minute walk test)
Measured: From Baseline to 3 months, 6 months and 1 year
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.
Measured: From Baseline to 3 months, 6 months and 1 year
Clinical success
No rehospitalizations or reinterventions for the underlying condition (e.g., tricuspid regurgitation/stenosis, heart failure);
Measured: From implant to 1 Year post-implant
Clinical success
Improvement from baseline in symptoms (e.g., NYHA improvement by >1 functional class); and/or Improvement from baseline in functional status (e.g., 6-min walk test improvement by >30 m); and/or Improvement from baseline in quality-of-life (e.g., Kansas City Cardiomyopathy Questionnaire improvement by >10)
Measured: From 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.
- First posted4 Apr 2023
- Study start1 Mar 2023
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VDyne, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vinny Podichetty, Study director, VDyne, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05797519
- Sponsor's protocol ID
- TPR0038-P
- Acronym
- VISTA
- Status last verified
- Aug 2026
- First submitted
- 6 Mar 2023
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation
- ClinicalTrials.gov ID
- NCT05797519
- Acronym / sponsor ID
- VISTA / TPR0038-P
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- VDyne, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 4 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical study is to collect safety and efficacy data of the VDyne System to support Conformitè Europëenne (CE) Mark of the VDyne System.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VDyne System Treatment Arm | Experimental | Device: VDyne Transcatheter Tricuspid Valve Replacement System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Severe or greater 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 or older at time of the index procedure.
Key exclusion criteria (43 listed)
- VDYNE SYSTEM SUITABILITY
- Patient anatomy (cardiac and vascular) is not suitable for the VDyne System as assessed by Imaging Core Labs, Sponsor and/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
- CLINICAL EXCLUSION CRITERIA (assessed by pre-procedural imaging)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VDyne Transcatheter Tricuspid Valve Replacement SystemAlso: VDyne System, VDyne Tricuspid System, VDyne Valve System, VDyne ValveThe study investigational device is the VDyne Transcatheter Tricuspid Valve Replacement System. | Device | VDyne System Treatment Arm |
Primary outcome
The percentage of subjects with Device- and/or Procedure-related Major Adverse Events (MAE)
Time frame: 30 days post-procedure
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 as measured by the Imaging Core Labs
Time frame: From Baseline to 1 month post-procedure
Change in tricuspid valve regurgitation as measured by the Imaging Core Labs
Changes in quality of life as measured by the KCCQ changes.
Time frame: From Baseline to 1 month post-procedure
Changes in quality of life as measured by the KCCQ changes. Higher score indicates worse outcome.
Changes in functional capacity (6-minute walk test)
Time frame: From Baseline to 1 month post-procedure
Changes in functional capacity (6-minute walk test)
Changes in symptom status (NYHA class)
Time frame: From Baseline to 1 month post-procedure
Changes in symptom status (NYHA class)
9 secondary outcomes
The percentage of subjects with Device- and/or Procedure-related Major Adverse Events (MAE)
Time frame: From Baseline to 1 year post-procedure
Change in tricuspid valve regurgitation as measured by the Imaging Core Lab
Time frame: From Baseline to 3 months, 6 months and 1 year
Intra-Procedural success
Time frame: From implant start time to procedure room exit
Clinical success
Time frame: From implant to 30 days post implant
Changes in symptom status (NYHA class)
Time frame: From Baseline to 3 months, 6 months and 1 year
Changes in functional capacity (6 minute walk test)
Time frame: From Baseline to 3 months, 6 months and 1 year
Changes in quality of life as measured by the KCCQ changes.
Time frame: From Baseline to 3 months, 6 months and 1 year
Clinical success
Time frame: From implant to 1 Year post-implant
Clinical success
Time frame: From implant to 1 Year post-implant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vinny Podichetty study director
VDyne, Inc.
21 sites in 11 countries: see every site and its status.
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 21 sites in 11 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 6 inclusion and 43 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 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Australia, Germany, Austria, Spain, United Kingdom and 6 more countries. 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 (+1.763.777.5969, 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) (time frame: 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?
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 13 Aug 2026.