An interventional study of VDyne Transcatheter Tricuspid Valve Replacement System in Tricuspid Regurgitation, Tricuspid Valve Disease and Tricuspid Valvular Disorders, sponsored by VDyne, Inc.. Recruiting at 11 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by VDyne, Inc. · Not applicable, Interventional, and Treatment
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Among 60 studies in Tricuspid Valve Insufficiency with a site in United States — 28 open to participants now, 36 under way, none of them phase 3. Tricuspid Valve Insufficiency · United States.
Among the 60 studies in Tricuspid Valve Insufficiency with a site in United States, this one is the 29th largest by planned enrollment of the 42 interventional ones that give a count, is one of 8 that started in 2024, is one of 39 with no phase, reaches primary completion later than 11 of the 35 other live ones, and was the 35th registered.
227 studies on the registry are indexed under Tricuspid Valve Insufficiency; 110 are open to participants now.
Browse Tricuspid Valve Insufficiency studies →28 of the 60 studies in Tricuspid Valve Insufficiency with a site in United States are open now. Recruiting first, the newest first:
Medtronic Cardiovascular · Sites in United States
Ages 18+
Laplace Interventional, Inc · Sites in United States
Ages 18–90
VDyne, Inc. · Sites in United States
Ages 18+
Jenscare Innovation Inc. · Sites in United States, Canada
Ages 21+
TRiCares · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 82 Tricuspid Valve Insufficiency studies recruiting now, 68 (83%) set no upper age limit and none (0%) stop at 75 or younger; 7 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
60 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 8 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 30 is below the median of 60 across 129 interventional studies indexed under Tricuspid Valve Insufficiency.
Median enrollment 63 across the 42 interventional studies, 464 across the 18 observational. Of the 19 that completed or were terminated, 7 (37%) have results posted.
This tab as a report to print or save as PDF → With an account.
37 of 60 have an industry lead sponsor. The 10 most frequent:
VDyne, Inc. is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
VDyne, Inc. has 3 studies filed under Tricuspid Valve Insufficiency — fewer than ten, so there is no comparison to draw.
8 of the studies in Tricuspid Valve Insufficiency with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05848284VDyne, Inc.Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation ( VISTA-US) | 2026-11-30 |
| NCT05825898Ottawa Heart Institute Research CorporationOutcome of Patients With Severe Functional TR According to Medical, Transcatheter or Surgical Treatment | 2026-12 |
| NCT06212193Innoventric LTDInnoventric Trillium™ Stent Graft Early Feasibility Study (EFS) | 2026-12-20 |
| NCT03382457Edwards LifesciencesClinical Study of Edwards Cardioband FIT Valve Repair System | 2026-12-31 |
| NCT06077201Vanderbilt University Medical CenterHome-Based Cardiac Rehabilitation Using a Novel Mobile Health Exercise Regimen Following Transcatheter Heart Valve Interventions | 2027-02-01 |
Add all 8 to your calendar (.ics) → With an account.
Among the 60 studies in Tricuspid Valve Insufficiency with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Also known as: VDyne System, VDyne Tricuspid System, VDyne Valve System, VDyne Valve
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).
Time frame: 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
Time frame: Baseline to 1 month after implant
Changes in symptom status (NYHA class)
Changes in symptom status (NYHA class)
Time frame: Baseline to 1 month after implant
Changes in functional capacity (6-minute walk test)
Changes in functional capacity (6-minute walk test)
Time frame: 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
Time frame: Baseline to 1 month after implant
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).
Time frame: 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
Time frame: 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
Time frame: 1 month after implant to 1 year post-implant
Rate of heart failure hospitalization
Rate of heart failure hospitalization
Time frame: 1 month after implant to 1 year post-implant
Changes in symptom status (NYHA class)
Changes in symptom status (NYHA class)
Time frame: 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)
Time frame: 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
Time frame: 1 month after implant to 1 year post-implant
Not enrolling at this site.
Not enrolling at this site.
Plan to share: No
Started Apr 2024 (actual). Primary completion is estimated for Nov 2026, 31 months after the start.
Of 55 industry-sponsored interventional studies with no phase under Tricuspid Valve Insufficiency, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 70. This study's planned 31 months is below that.
Counting every sponsor, half of 86 studies reached it within 38 months; a quarter within 23 and three quarters within 58.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Tricuspid Valve Insufficiency →
VDyne, Inc.