Tricuspid RegurgitationNCT06368401
A First in Human Study for the Versa Device for Tricuspid Regurgitation
A study testing Versa Implant in people with Tricuspid Regurgitation, run by Versa Vascular, Inc at 5 sites in 3 countries.
Trial summary
This study is prospective, non-randomized, single-arm,first in human study to evaluate the safety and feasibility of the Versa Vascular System for intervention in adults with severe tricuspid regurgitation who are not surgical candidates. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Regurgitation
- What is being tested?
- Versa Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 5 Aug 2024to 31 Dec 2032
- 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
- Tricuspid regurgitation (TR) associated symptoms despite optimal medical treatment.
- TR ≥ 3 as determined by the assessment of a transthoracic echocardiogram or transesophageal echocardiogram.
- The local multi-disciplinary heart team agrees that the participant is a poor candidate for surgery.
- Age ≥ 18 years at the time of consent.
- Ability and willingness to provide written informed consent prior to any study related procedure(s).
Who cannot join
- Severe pulmonary hypertension.
- Severe uncontrolled hypertension Systolic Blood Pressure (SBP) ≥ 180 mmHg and/or Diastolic Blood Pressure (DBP) ≥ 110 mmHg.
- Any condition that would interfere with the Versa procedure, such as prior tricuspid valve repair or tricuspid valve leaflet anatomy which may preclude successful device implantation, pacemaker or Implantable Cardioverter Defibrillator (ICD) leads that would prevent appropriate placement or visualization of Versa implant, Ebstein Anomaly (normal annulus position, but valve leaflets attached to walls and septum of the right ventricle), tricuspid valve anatomy non-evaluable by echocardiography.
- Known allergy to antiplatelet therapy, heparin, or to device materials.
- Femoral venous mass or thrombus or vegetation.
- Tricuspid valve anatomy not compatible with the Versa implant
Show all 21Show fewer
- Undergone any heart valve surgery within prior 60 days.
- Tricuspid valve stenosis - Defined as a tricuspid valve orifice of ≤ 4.0 cm2.
- Severe mitral regurgitation.
- Left Ventricular Ejection Fraction (LVEF) ≤ 20%
- Active endocarditis, other ongoing infection requiring antibiotic therapy.
- Myocardial infarction or percutaneous coronary intervention within prior 30 days.
- Cardiogenic shock or the need for inotropic support or hemodynamic support device (e.g., intra-aortic balloon pump).
- Cerebrovascular Accident (CVA) within prior 30 days
- Active gastrointestinal (GI) bleeding
- Life expectancy of less than 12 months independent of tricuspid valvular disease.
- Subject currently participating in another clinical study (not yet completed primary endpoint).
- Pregnant or nursing subjects or those who plan pregnancy during the study.
- The presence of anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the eye of the investigator, limits the subject's ability to participate in the clinical investigation or comply with follow-up requirements.
- Absence of appropriate venous access.
- Unwillingness to complete the required follow-up visits.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Chile3 sites
Hospital Clínico San Borja Arriarán
Santiago
Pontificia Universidad Católica
Santiago
Hospital Las Higueras
Talcahuano
About this study
Official title: Transcatheter Tricuspid Repair Utilizing the Versa Vascular Repair System
This study is prospective, non-randomized, single-arm,first in human study to evaluate the safety and feasibility of the Versa Vascular System for intervention in adults with severe tricuspid regurgitation who are not surgical candidates.
- Conditions
- Tricuspid Regurgitation
- Being tested
- Versa Implant
- 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.
Versa ImplantDevice
The Versa Vascular Implant and Delivery System consists of a percutaneously delivered, permanent right-atrial implant and the delivery catheter that is used to first position the implant over the native valve orifice and to then place the implant.
| Study group | Role | What they receive |
|---|---|---|
| Implant | Experimental | Participants who pass all screening criteria will undergo a percutaneous procedure for the implantation of a permanent tricuspid repair device. Participants will be followed for 1 year to evaluate the safety and feasibility of the Versa System procedure and the Versa Tricuspid Repair Implant. Receives: Device: Versa Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Procedural Success
Successful in Versa Vascular Device implantation, and residual TR grade equivalent to a reduction of at least 1 grade of TR when compared to TR evaluated prior to implantation of the Versa Vascular Device.
Measured: Immediately after the procedure
Incidence of major adverse events (MAE)
Freedom from procedure and/or device related Major Adverse Events (MAE). MAE are defined as all-cause mortality, reoperation, or reintervention for tricuspid regurgitation prior to hospital discharge.
Measured: (up to 7 days) from date of procedure to date of patient discharge from hospital
Secondary outcomes (1)
Tricuspid Regurgitation Severity Change
Percentage of patients with tricuspid regurgitation reduced by at least one grade. Echocardiographic analysis of Tricuspid regurgitation at 90 days. TR grade at day 90 will be compared against TR grade at the time of implantation.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start5 Aug 2024
- Primary completion30 Jul 2027 (estimated)
- Study completion31 Dec 2032 (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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Versa Vascular, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cardiovascular Research Foundation, New York
- Responsible party
- Sponsor
- Investigators
- Mark Webster, MD, Principal investigator, Auckland City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368401
- Sponsor's protocol ID
- TP_01428
- Status last verified
- Aug 2026
- First submitted
- 7 Apr 2024
- Last updated
- 28 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcatheter Tricuspid Repair Utilizing the Versa Vascular Repair System
- ClinicalTrials.gov ID
- NCT06368401
- Acronym / sponsor ID
- TP_01428
- Conditions
- Tricuspid Regurgitation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Versa Vascular, IncIndustry (pharma, biotech, devices)
- Collaborators
- Cardiovascular Research Foundation, New York
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 16 Apr 2024 (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.
This study is prospective, non-randomized, single-arm,first in human study to evaluate the safety and feasibility of the Versa Vascular System for intervention in adults with severe tricuspid regurgitation who are not surgical candidates.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implant | Experimental | Device: Versa ImplantParticipants who pass all screening criteria will undergo a percutaneous procedure for the implantation of a permanent tricuspid repair device. Participants will be followed for 1 year to evaluate the safety and feasibility of the Versa System procedure and the Versa Tricuspid Repair Implant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Tricuspid regurgitation (TR) associated symptoms despite optimal medical treatment.
- TR ≥ 3 as determined by the assessment of a transthoracic echocardiogram or transesophageal echocardiogram.
- The local multi-disciplinary heart team agrees that the participant is a poor candidate for surgery.
- Age ≥ 18 years at the time of consent.
- Ability and willingness to provide written informed consent prior to any study related procedure(s).
Key exclusion criteria (21 listed)
- Severe pulmonary hypertension.
- Severe uncontrolled hypertension Systolic Blood Pressure (SBP) ≥ 180 mmHg and/or Diastolic Blood Pressure (DBP) ≥ 110 mmHg.
- Any condition that would interfere with the Versa procedure, such as prior tricuspid valve repair or tricuspid valve leaflet anatomy which may preclude successful device implantation, pacemaker or Implantable Cardioverter Defibrillator (ICD) leads that would prevent appropriate placement or visualization of Versa implant, Ebstein Anomaly (normal annulus position, but valve leaflets attached to walls and septum of the right ventricle), tricuspid valve anatomy non-evaluable by echocardiography.
- Known allergy to antiplatelet therapy, heparin, or to device materials.
- Femoral venous mass or thrombus or vegetation.
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 |
|---|---|---|
| Versa ImplantThe Versa Vascular Implant and Delivery System consists of a percutaneously delivered, permanent right-atrial implant and the delivery catheter that is used to first position the implant over the native valve orifice and to then place the implant. | Device | Implant |
Primary outcome
Acute Procedural Success
Time frame: Immediately after the procedure
Successful in Versa Vascular Device implantation, and residual TR grade equivalent to a reduction of at least 1 grade of TR when compared to TR evaluated prior to implantation of the Versa Vascular Device.
Incidence of major adverse events (MAE)
Time frame: (up to 7 days) from date of procedure to date of patient discharge from hospital
Freedom from procedure and/or device related Major Adverse Events (MAE). MAE are defined as all-cause mortality, reoperation, or reintervention for tricuspid regurgitation prior to hospital discharge.
1 secondary outcome
Tricuspid Regurgitation Severity Change
Time frame: 90 days
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 28 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Tricuspid Regurgitation
Recruiting
The TRICURE EFS Study
Tricuspid Valve Regurgitation, Heart Valve Diseases
Active, not recruiting
TRISCEND JAPAN Study
Tricuspid Valve Regurgitation, Heart Valve Diseases
Recruiting
First-in-man Trial to Assess the Safety, Performance and Clinical Benefit of the TRICENTO G2 Transcatheter Valve System for Tricuspid Regurgitation
Symptomatic Tricuspid Regurgitation (TR) Graded as Severe or Greater
Recruiting
The TRICURE US IDE Pivotal Study
Tricuspid Regurgitation (TR)
Recruiting
EFS of the DUO System for Tricuspid Regurgitation
Tricuspid Regurgitation, Tricuspid Valve Insufficiency
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. This study is not recruiting at the moment.
Mark Webster, MD principal investigator
Auckland City Hospital
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Versa Implant in people with Tricuspid Regurgitation, run by Versa Vascular, Inc at 5 sites in 3 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 5 inclusion and 21 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: under way, not looking for participants, as of the sponsor's last update on 28 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 5 sites in Chile, Brazil, New Zealand. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Procedural Success (time frame: Immediately after the procedure). The study lists 2 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 28 Aug 2026.