Mitral Regurgitation (MR)NCT07917208
Early Feasibility Study of the Capstan Medical TMVR System
A study testing Capstan Compass Robotic System for Transcatheter Mitral Valve Replacement in people with Mitral Regurgitation (MR), run by Capstan Medical at 3 sites in United States.
Trial summary
This early feasibility study is evaluating the safety and performance of the Capstan Compass Robotic System™ for transcatheter mitral valve replacement in patients with symptomatic, moderate-to-severe or severe mitral regurgitation who are unsuitable for surgical repair or transcatheter edge-to-edge repair. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation (MR)
- What is being tested?
- Capstan Compass Robotic System for Transcatheter Mitral Valve Replacement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2026to Mar 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
- Age ≥ 18 years at the time of consent.
- Moderate-to-severe or severe mitral regurgitation.
- NYHA II or greater symptoms.
- The participant is considered to be at elevated, but not prohibitive, surgical risk for mitral valve replacement, as determined by the local multi-disciplinary heart team and/or a validated surgical risk assessment tool (e.g., STS PROM).
- The local multi-disciplinary heart team determines that surgical mitral valve replacement is not the preferred treatment option and that the participant is an appropriate candidate for treatment with the Capstan System.
- The local multi-disciplinary heart team determines that the participant is unsuitable for mitral transcatheter edge-to-edge repair (mTEER) due to anatomical, technical, and/or clinical reasons.
- The local multi-disciplinary heart team deems heart failure management is optimized based on participant characteristics and applicable guidelines.
- Ability and willingness to provide written informed consent prior to any study related procedure(s)
Who cannot join
- LVEF < 25%
- Anatomic features unsuitable for the Capstan System.
- Inappropriate anatomy for femoral venous introduction and delivery of the Capstan System.
- Severe mitral stenosis.
- Untreated severe aortic or pulmonic valve disease (stenosis or regurgitation).
- Untreatable severe right ventricular dysfunction or severe tricuspid valve disease.
Show all 29Show fewer
- Evidence of intracardiac thrombus, vegetation, or mass.
- Prior mitral valve intervention that would interfere with the appropriate placement of the Capstan Valve.
- Any cardiac or vascular procedure performed within 30 days prior to procedure.
- Myocardial infarction within 30 days prior to enrollment.
- Cardiac resynchronization therapy (CRT) device implanted within 30 days of procedure.
- Active endocarditis, other ongoing infection requiring antibiotic therapy.
- Stroke or transient ischemic attack (TIA) within 30 days of procedure.
- Active peptic ulcer or active gastrointestinal bleeding.
- PASP > 70mmHg or PVR > 5 Wood units after vasodilator challenge.
- End-stage renal failure on dialysis or eGFR ≤ 25.
- Concurrent medical condition with a life expectancy of less than 12 months.
- Participant is on the waiting list for a heart transplant or has had a prior heart transplant.
- Pregnant (participants of childbearing age are required to have a negative pregnancy test).
- Known allergy or hypersensitivity to device materials (e.g. nitinol, PET), or a documented allergy to heparin, that cannot be adequately medicated; a history of HIT, or contraindication to required antithrombotic therapies.
- Contraindication to or inability to tolerate the protocol-required therapeutic anticoagulation regimen for the 6-months post-procedure period.
- Participant is contraindicated for transesophageal echocardiography (TEE).
- Any condition making it unlikely the patient will be able to complete all protocol procedures (including compliance with guideline directed medical therapy) and follow-up visits.
- Hemodynamic instability requiring inotropic or mechanical support within 30 days of the procedure.
- Clinically significant untreated coronary artery disease requiring revascularization.
- Chronic Obstructive Pulmonary Disease (COPD) on continuous O2 therapy.
- Refusal of blood products.
- Currently enrolled in any other pre-approval investigational study (does not apply to long-term post-market studies unless these studies might clinically interfere with the current study endpoints (e.g., limit use of study-required medication, etc.)).
- Planned cardiac intervention in the next 12 months.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
The Christ Hospital
Cincinnati, Ohio, 45219
Suzy Frakes
Santiago Garcia, MD
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
Kathryn Adams
Colin Barker, MD
Kaiser Permanente
San Francisco, California, 94115
Cristina Casias-Perez
Jacob Mishell, MD
About this study
This early feasibility study is evaluating the safety and performance of the Capstan Compass Robotic System™ for transcatheter mitral valve replacement in patients with symptomatic, moderate-to-severe or severe mitral regurgitation who are unsuitable for surgical repair or transcatheter edge-to-edge repair.
- Conditions
- Mitral Regurgitation (MR)
- Being tested
- Capstan Compass Robotic System for Transcatheter Mitral Valve Replacement
- Keywords
- Transcatheter Mitral Valve Replacement, TMVR, Mitral Regurgitation, Capstan System, Structural Heart Disease, Mitral Valve Disease
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capstan Compass Robotic System for Transcatheter Mitral Valve ReplacementDevice
Capstan System includes the Capstan Mitral Valve
| Study group | Role | What they receive |
|---|---|---|
| TMVR | Experimental | Participants will undergo transcatheter mitral valve replacement Receives: Device: Capstan Compass Robotic System for Transcatheter Mitral Valve Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint
Evaluate serious adverse events associated with the delivery and/or implantation of the device.
Measured: 30 Days
Primary Performance Endpoint
Successful insertion, delivery, deployment, and retrieval of the delivery catheter defined as the proportion of patients presented as n/N (%) with device successfully inserted, delivered, deployed, and retrieved as defined by MVARC.
Measured: At the end of the procedure
Primary Performance Endpoint
Successful deployment of the implant in the intended target location defined as the proportion of patients presented as n/N (%) with implant successfully deployed in the intended target location as defined by MVARC.
Measured: At the end of the procedure
Primary Performance Endpoint
Freedom from emergency surgery related to the investigational device or procedure based upon reported adverse events.
Measured: At the end of the procedure
Primary Performance Endpoint
Freedom from device- or procedure-related mortality based upon reported adverse events.
Measured: 30 Days
Primary Performance Endpoint
Freedom from emergency surgery related to the investigational device or procedure based upon reported adverse events.
Measured: 30 Days
Primary Performance Endpoint
Freedom from device- or procedure-related reintervention based upon reported adverse events.
Measured: 30 Days
Secondary outcomes (7)
Secondary Safety Endpoint
Rate of hemolysis and hemolytic anemia from reported adverse events.
Measured: 30 Days
Secondary Safety Endpoint
Rate of anaphylactic reactions from reported adverse events.
Measured: 30 Days
Secondary Performance Endpoint
Reduction in mitral regurgitation grade from echo analysis.
Measured: Through 5 Years
Secondary Performance Endpoint
The degree of improvement in symptoms and Quality of Life as measured by NYHA functional class.
Measured: Through 5 Years
Secondary Performance Endpoint
The degree of improvement in symptoms and Quality of Life as measured by KCCQ-12.
Measured: Through 5 Years
Secondary Performance Endpoint
The degree of improvement in symptoms and Quality of Life as measured by 6MWT.
Measured: Through 5 Years
Secondary Performance Endpoint
Robotic Technical Success defined as the absence of manual conversion.
Measured: At the end of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionMar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Regurgitation (MR)Studies 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capstan Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07917208
- Sponsor's protocol ID
- CL08378
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Study of the Capstan Medical TMVR System
- ClinicalTrials.gov ID
- NCT07917208
- Acronym / sponsor ID
- CL08378
- Conditions
- Mitral Regurgitation (MR)
- Keywords
- Transcatheter Mitral Valve Replacement, TMVR, Mitral Regurgitation, Capstan System, Structural Heart Disease, Mitral Valve Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Capstan MedicalIndustry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Mar 2032 (estimated)
- First posted
- 4 Nov 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 early feasibility study is evaluating the safety and performance of the Capstan Compass Robotic System™ for transcatheter mitral valve replacement in patients with symptomatic, moderate-to-severe or severe mitral regurgitation who are unsuitable for surgical repair or transcatheter edge-to-edge repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TMVR | Experimental | Device: Capstan Compass Robotic System for Transcatheter Mitral Valve ReplacementParticipants will undergo transcatheter mitral valve replacement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years at the time of consent.
- Moderate-to-severe or severe mitral regurgitation.
- NYHA II or greater symptoms.
- The participant is considered to be at elevated, but not prohibitive, surgical risk for mitral valve replacement, as determined by the local multi-disciplinary heart team and/or a validated surgical risk assessment tool (e.g., STS PROM).
- The local multi-disciplinary heart team determines that surgical mitral valve replacement is not the preferred treatment option and that the participant is an appropriate candidate for treatment with the Capstan System.
Key exclusion criteria (29 listed)
- LVEF < 25%
- Anatomic features unsuitable for the Capstan System.
- Inappropriate anatomy for femoral venous introduction and delivery of the Capstan System.
- Severe mitral stenosis.
- Untreated severe aortic or pulmonic valve disease (stenosis or regurgitation).
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 |
|---|---|---|
| Capstan Compass Robotic System for Transcatheter Mitral Valve ReplacementCapstan System includes the Capstan Mitral Valve | Device | TMVR |
Primary outcome
Primary Safety Endpoint
Time frame: 30 Days
Evaluate serious adverse events associated with the delivery and/or implantation of the device.
Primary Performance Endpoint
Time frame: At the end of the procedure
Successful insertion, delivery, deployment, and retrieval of the delivery catheter defined as the proportion of patients presented as n/N (%) with device successfully inserted, delivered, deployed, and retrieved as defined by MVARC.
Primary Performance Endpoint
Time frame: At the end of the procedure
Successful deployment of the implant in the intended target location defined as the proportion of patients presented as n/N (%) with implant successfully deployed in the intended target location as defined by MVARC.
Primary Performance Endpoint
Time frame: At the end of the procedure
Freedom from emergency surgery related to the investigational device or procedure based upon reported adverse events.
Primary Performance Endpoint
Time frame: 30 Days
Freedom from device- or procedure-related mortality based upon reported adverse events.
Primary Performance Endpoint
Time frame: 30 Days
Freedom from emergency surgery related to the investigational device or procedure based upon reported adverse events.
Primary Performance Endpoint
Time frame: 30 Days
Freedom from device- or procedure-related reintervention based upon reported adverse events.
7 secondary outcomes
Secondary Safety Endpoint
Time frame: 30 Days
Secondary Safety Endpoint
Time frame: 30 Days
Secondary Performance Endpoint
Time frame: Through 5 Years
Secondary Performance Endpoint
Time frame: Through 5 Years
Secondary Performance Endpoint
Time frame: Through 5 Years
Secondary Performance Endpoint
Time frame: Through 5 Years
Secondary Performance Endpoint
Time frame: At the end of the procedure
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 4 Nov 2026.
Related trials for Mitral Regurgitation (MR)
Not yet recruiting
Early Feasibility Study of NeoChord Transcatheter Mitral Repair System
Degenerative Mitral Regurgitation, Degenerative Mitral Regurgitation (MR) Due to Leaflet Prolapse
Active, not recruiting
Use of Force Feedback Instruments With the da Vinci Surgical System, Model IS5000 for Mitral Valve Repair
Mitral Regurgitation (MR)
Recruiting
PRECISE-AFMR I: Transcatheter Mitral Valve Edge-to-Edge Repair for Atrial Functional Mitral Regurgitation in Patients at High Surgical Risk
Atrial Functional, Mitral Regurgitation (MR)
RecruitingObservational study
Examination of Nociscan Impact on Low Back Pain Surgical Outcomes
Low Back Pain
Recruiting
EXPLORE MRace (GE): Early Feasibility Experience of Posterior Leaflet Restoration to Reduce Mitral Regurgitation Using the MRace Implant
Mitral Valve Disease
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capstan Compass Robotic System for Transcatheter Mitral Valve Replacement in people with Mitral Regurgitation (MR), run by Capstan Medical at 3 sites in United States.
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 8 inclusion and 29 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: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 Courtney Elliott (4087814445, courtney.elliott@capstanmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint (time frame: 30 Days). The study lists 7 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 4 Nov 2026.