Testing Transcatheter Mitral Valve Repair for degenerative mitral regurgitation
Official title: FIH ITA Study - Vesalius TMVr System for Symptomatic Degenerative Mitral Regurgitation
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
- 1 group
- One site, in Vancouver
- Recruiting
Interventions
- Medical device
Transcatheter Mitral Valve Repair
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.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
St. Paul's Hospital
Vancouver
Eligibility Criteria
See who this study is looking for28 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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)
- +Suitable anatomy for the Vesalius TMVr System as determined by pre-procedure imaging
- +Willing to adhere to study follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → schedule for up to 5 years
- +Written informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → provided
- +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
Exclusion
- −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 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-upFollow-upContinued check-ins after the treatment part is finished.Read more → 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
- −Previous valvular surgery
- −Previous atrial septal surgery
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is checking whether a device performs as intended and can be used practically.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
Everyone in this study is in one group and receives Transcatheter Mitral Valve Repair.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 19 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 5 people.
The study is currently expected to finish around April 2032.
The main measurement is taken over: 30 Days.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Safety - Number of Participants Experiencing All-Cause Mortality — measured over 30 Days.
Number of Participants Achieving Technical Success — measured over Measured at Day 0 (Procedure Exit).
Number of participants Achieving Device Success — measured over 30 Days.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07470788 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About 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.
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 19 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 19 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 30 Days.
The study as a whole is currently expected to finish around 2032-04.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 5 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Vancouver, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.