Degenerative Mitral RegurgitationNCT07470788
FIH ITA Study - Vesalius TMVr System for Symptomatic Degenerative Mitral Regurgitation
A study testing Transcatheter Mitral Valve Repair in people with Degenerative Mitral Regurgitation, run by Vesalius Cardiovascular Inc. at 1 site in Canada.
Trial summary
This first-in-human study evaluates the safety and performance of the Vesalius Transcatheter Mitral Valve Repair (TMVr) System in patients with degenerative mitral regurgitation. The study will enroll patients who are at high or prohibitive risk for conventional surgical repair or replacement of the mitral valve. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Degenerative Mitral Regurgitation
- What is being tested?
- Transcatheter Mitral Valve Repair
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2026to Apr 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 19 years
- Moderate to severe (≥3+) or severe (≥4+) degenerative mitral valve regurgitation (per American Society of Echocardiography (ASE) guidelines, depicted in Figure 14)
- New York Heart Association (NYHA) Functional Class II, III, or Ambulatory (IV)
- Elevated risk for surgical mitral valve repair: Society of Thoracic Surgery (STS) predicted risk of mortality (PROM) of ≥6% as determined by the STS Risk Calculator for Surgical Repair of Primary Mitral Regurgitation [1], as well as patient operative risk assessment by the Heart Team
- Suitable anatomy for the Vesalius TMVr System as determined by pre-procedure imaging
- Willing to adhere to study follow-up schedule for up to 5 years
- Written informed consent provided
Who cannot join
- Anatomy ideally suitable for other approved transcatheter therapy (i.e. TEER candidate)
- LV ejection fraction < 30%
- Active bacterial endocarditis within 60 days of planned index procedure
- Dialysis-dependent renal insufficiency
- Body Mass Index (BMI) ≥ 45 kg/m2
- Previous valvular surgery
Show all 21Show fewer
- Previous atrial septal surgery
- Previous endovascular structural procedure(s) and/or device(s) within 6 months
- Severe mitral annular calcification (MAC) prohibiting device implantation
- Severe annulus or leaflet calcification
- Leaflet perforation
- Contraindication to anticoagulation / antiplatelet therapy
- Patients with sensitivity to nickel or contrast media
- Concomitant severe tricuspid regurgitation
- Absence of conventional medial and lateral papillary muscle groups
- Femoral vein cannot accommodate a 29 F catheter
- Contraindication to Transoesophageal echocardiography (TEE)
- Life expectancy <1 year due to non-cardiac comorbidities.
- Presence of other anatomic, comorbid conditions, or other medical conditions that could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results, in the opinion of the Heart Team
- Participation in other clinical investigation
- Pregnant or planning to become pregnant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
St. Paul's Hospital
Vancouver
Elizabeth Grieve, 604-682-2344, elizabeth.grieve@phc.ca
About this study
Official title: A First-in-Human Investigational Testing Authorization Study Evaluating the Safety and Performance of the Vesalius Transcatheter Mitral Valve Repair System in Patients With Severe, Symptomatic Degenerative Mitral Regurgitation
This first-in-human study evaluates the safety and performance of the Vesalius Transcatheter Mitral Valve Repair (TMVr) System in patients with degenerative mitral regurgitation. The study will enroll patients who are at high or prohibitive risk for conventional surgical repair or replacement of the mitral valve. Participants will receive implantation of the Vesalius TMVr System and will be followed to assess clinical outcomes, device performance, and any adverse events.
Read the detailed description
This first-in-human study is designed to evaluate the safety and performance of the Vesalius Transcatheter Mitral Valve Repair (TMVr) System in patients with symptomatic, severe or moderate-to-severe degenerative mitral regurgitation who are at elevated surgical risk. The study will enroll up to five patients in Canada to assess procedural feasibility, technical performance, and short-term clinical outcomes following device implantation. Endpoints are based on Mitral Valve Academic Research Consortium (MVARC) definitions, including measures of procedural and device success, freedom from major adverse events, and technical achievement of device deployment. Safety, functional, and hemodynamic parameters will be monitored at predefined intervals, and follow-up will include assessment of valve function, adverse events, and device performance. This study will provide preliminary data to support the further development and evaluation of the Vesalius TMVr System.
- Conditions
- Degenerative Mitral Regurgitation
- Being tested
- Transcatheter Mitral Valve Repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Mitral Valve RepairDevice
The Vesalius Transcatheter Mitral Valve Repair (TMVr) System is a novel transcatheter device designed to percutaneously deliver an implant to repair the native mitral valve in patients with degenerative mitral regurgitation. The system uses an adjustable ePTFE net to reduce or eliminate mitral regurgitation. The device is delivered via a minimally invasive transcatheter approach, allowing precise positioning and deployment in high-risk patients not suitable for conventional surgery.
| Study group | Role | What they receive |
|---|---|---|
| Vesalius TMVr System | Experimental | Participants in this arm will undergo implantation with the Vesalius Transcatheter Mitral Valve Repair (TMVr) System according to the study protocol. All procedures will be performed by trained interventional cardiologists, and participants will be followed for safety, device performance, and clinical outcomes at predefined intervals. Receives: Device: Transcatheter Mitral Valve Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Number of Participants Experiencing All-Cause Mortality
Number of participants experiencing all-cause mortality post-implant, prior to discharge, and through the 30-day follow-up period.
Measured: 30 Days
Number of Participants Achieving Technical Success
Number of participants achieving successful delivery and positioning of the device, absence of procedural mortality, and freedom from emergency cardiovascular surgery or reintervention related to the device through procedure exit.
Measured: Measured at Day 0 (Procedure Exit)
Number of participants Achieving Device Success
Number of patients achieving successful deployment and correct anatomical positioning of the device, absence of procedural mortality or stroke, and freedom from unplanned surgical or interventional procedures related to the device through 30 days.
Measured: 30 Days
Secondary outcomes (2)
Number of Participants by Mitral Regurgitation (MR) Severity Grade
Assessment of MR severity evaluated by transthoracic/transesophageal echocardiography (TTE/TEE). MR severity is categorized using standard clinical grading: Grade 0 (None/Trace), Grade 1+ (Mild), Grade 2+ (Moderate), Grade 3+ (Severe), and Grade 4+ (Very Severe). Higher grades indicate worse outcome severity.
Measured: 30 Days
Number of Participants Experiencing Major Adverse Events (MAE)
Occurrence of serious cardiovascular, cerebrovascular, or renal events related to the device or procedure.
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study startAug 2026 (estimated)
- Primary completionApr 2032 (estimated)
- Study completionApr 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Mitral 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
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vesalius Cardiovascular Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07470788
- Sponsor's protocol ID
- VES-CPT-002
- Status last verified
- Aug 2026
- First submitted
- 9 Mar 2026
- Last updated
- 19 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 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human Investigational Testing Authorization Study Evaluating the Safety and Performance of the Vesalius Transcatheter Mitral Valve Repair System in Patients With Severe, Symptomatic Degenerative Mitral Regurgitation
- ClinicalTrials.gov ID
- NCT07470788
- Acronym / sponsor ID
- VES-CPT-002
- Conditions
- Degenerative Mitral Regurgitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Vesalius Cardiovascular Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2026 (estimated)
- Primary completion
- Apr 2032 (estimated)
- Study completion
- Apr 2032 (estimated)
- First posted
- 13 Mar 2026 (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 first-in-human study evaluates the safety and performance of the Vesalius Transcatheter Mitral Valve Repair (TMVr) System in patients with degenerative mitral regurgitation. The study will enroll patients who are at high or prohibitive risk for conventional surgical repair or replacement of the mitral valve. Participants will receive implantation of the Vesalius TMVr System and will be followed to assess clinical outcomes, device performance, and any adverse events.
Detailed description
This first-in-human study is designed to evaluate the safety and performance of the Vesalius Transcatheter Mitral Valve Repair (TMVr) System in patients with symptomatic, severe or moderate-to-severe degenerative mitral regurgitation who are at elevated surgical risk. The study will enroll up to five patients in Canada to assess procedural feasibility, technical performance, and short-term clinical outcomes following device implantation. Endpoints are based on Mitral Valve Academic Research Consortium (MVARC) definitions, including measures of procedural and device success, freedom from major adverse events, and technical achievement of device deployment. Safety, functional, and hemodynamic parameters will be monitored at predefined intervals, and follow-up will include assessment of valve function, adverse events, and device performance. This study will provide preliminary data to support the further development and evaluation of the Vesalius TMVr System.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vesalius TMVr System | Experimental | Device: Transcatheter Mitral Valve RepairParticipants in this arm will undergo implantation with the Vesalius Transcatheter Mitral Valve Repair (TMVr) System according to the study protocol. All procedures will be performed by trained interventional cardiologists, and participants will be followed for safety, device performance, and clinical outcomes at predefined intervals. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 19 years
- Moderate to severe (≥3+) or severe (≥4+) degenerative mitral valve regurgitation (per American Society of Echocardiography (ASE) guidelines, depicted in Figure 14)
- New York Heart Association (NYHA) Functional Class II, III, or Ambulatory (IV)
- Elevated risk for surgical mitral valve repair: Society of Thoracic Surgery (STS) predicted risk of mortality (PROM) of ≥6% as determined by the STS Risk Calculator for Surgical Repair of Primary Mitral Regurgitation [1], as well as patient operative risk assessment by the Heart Team
- Suitable anatomy for the Vesalius TMVr System as determined by pre-procedure imaging
Key exclusion criteria (21 listed)
- Anatomy ideally suitable for other approved transcatheter therapy (i.e. TEER candidate)
- LV ejection fraction < 30%
- Active bacterial endocarditis within 60 days of planned index procedure
- Dialysis-dependent renal insufficiency
- Body Mass Index (BMI) ≥ 45 kg/m2
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 |
|---|---|---|
| Transcatheter Mitral Valve RepairThe Vesalius Transcatheter Mitral Valve Repair (TMVr) System is a novel transcatheter device designed to percutaneously deliver an implant to repair the native mitral valve in patients with degenerative mitral regurgitation. The system uses an adjustable ePTFE net to reduce or eliminate mitral regurgitation. The device is delivered via a minimally invasive transcatheter approach, allowing precise positioning and deployment in high-risk patients not suitable for conventional surgery. | Device | Vesalius TMVr System |
Primary outcome
Safety - Number of Participants Experiencing All-Cause Mortality
Time frame: 30 Days
Number of participants experiencing all-cause mortality post-implant, prior to discharge, and through the 30-day follow-up period.
Number of Participants Achieving Technical Success
Time frame: Measured at Day 0 (Procedure Exit)
Number of participants achieving successful delivery and positioning of the device, absence of procedural mortality, and freedom from emergency cardiovascular surgery or reintervention related to the device through procedure exit.
Number of participants Achieving Device Success
Time frame: 30 Days
Number of patients achieving successful deployment and correct anatomical positioning of the device, absence of procedural mortality or stroke, and freedom from unplanned surgical or interventional procedures related to the device through 30 days.
2 secondary outcomes
Number of Participants by Mitral Regurgitation (MR) Severity Grade
Time frame: 30 Days
Number of Participants Experiencing Major Adverse Events (MAE)
Time frame: 30 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 19 Aug 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter Mitral Valve Repair in people with Degenerative Mitral Regurgitation, run by Vesalius Cardiovascular Inc. at 1 site in Canada.
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 7 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: looking for participants now, as of the sponsor's last update on 19 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 1 site in Canada. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - Number of Participants Experiencing All-Cause Mortality (time frame: 30 Days). The study lists 3 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 19 Aug 2026.