Mitral RegurgitationNCT06600191
Capstan Medical TMVR Study: FIH
A study testing Capstan System transcatheter mitral valve replacement in people with Mitral Regurgitation, run by Capstan Medical at 4 sites in 4 countries.
Trial summary
This study is a prospective, multi-center, non-randomized first in human study to evaluate the safety and feasibility of the Capstan Medical TMVR System for intervention in adults with moderate-severe or greater mitral 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
- Mitral Regurgitation
- What is being tested?
- Capstan System transcatheter mitral valve replacement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 24 Feb 2025to Dec 2031
- 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-severe (3+) or severe (4+) mitral regurgitation
- NYHA II or greater symptoms despite optimal medical treatment.
- The local multi-disciplinary heart team agrees that TMVR is the preferred treatment over surgical intervention or other available treatment options (such as TEER).
- Ability and willingness to provide written informed consent prior to any study related procedure(s).
Who cannot join
- LVEF less than 20%
- Anatomic features (e.g., annular dimensions, neo-LVOT area, transfemoral and transseptal access, excessive MAC) unsuitable for the Capstan System
- Severe aortic valve stenosis or regurgitation
- Severe mitral stenosis
- Severe right ventricular dysfunction or severe tricuspid valve disease
- Evidence of intracardiac thrombus, vegetation, or mass
Show all 23Show fewer
- Prior mitral valve intervention that would interfere with the appropriate placement of the Capstan Valve
- Any percutaneous coronary, carotid, or other endovascular intervention within 30 days prior to procedure
- Myocardial infarction within 30 days prior to procedure
- 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
- Severe pulmonary arterial hypertension with fixed PASP greater than 85mmHg
- End-stage renal failure on dialysis
- Life expectancy less than 1 year
- Subject 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 to antiplatelet therapy, heparin, or to device materials
- Inability to tolerate anticoagulation or antiplatelet therapies
- Absence of appropriate venous access
- Unable to have transesophageal echocardiography
- Unwillingness to complete the required follow-up visits
Trial locations and contacts
4 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 4 countries
Australia1 site, 1 recruiting
- Not yet recruiting
Monash Health, Victorian Heart Hospital
Melbourne
Robert Gooley, +61 (03) 7511 1111, research@MonashHealth.org
Brazil1 site, 1 recruiting
- Not yet recruiting
Instituto do Coração de São Paulo Incor
São Paulo
Alexandre Abizaid, MD, +55 11 2661-5000, incor_trials@incor.usp.br
Chile1 site, 1 recruiting
- Recruiting
Pontificia Universidad Católica de Chile
Santiago
Gonzalo Javier Martinez Rodriguez, +56 2 23543633, gfloresp@uc.cl
New Zealand1 site, 1 recruiting
- Recruiting
Auckland City Hospital
Auckland, 1023
Mark Webster, MD, +64 21 241 2758, charissa@adhb.govt.nz
About this study
Official title: Capstan Medical TMVR Study: First-in-Human Evaluation of the Capstan TMVR System
This study is a prospective, multi-center, non-randomized first in human study to evaluate the safety and feasibility of the Capstan Medical TMVR System for intervention in adults with moderate-severe or greater mitral regurgitation who are not surgical candidates.
- Conditions
- Mitral Regurgitation
- Being tested
- Capstan System transcatheter mitral valve replacement
- Keywords
- TMVR, mitral regurgitation
- 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 System transcatheter mitral valve replacementDevice
This is a first human use trial exploring a novel transcatheter mitral valve replacement implant and electro-mechanical delivery system. The device offers a minimally invasive repair for patients who have at symptomatic regurgitation who are otherwise ineligable for surgical intervention, or who have no other prospects for treatment and in whom medical therapy has already been optimised.
| 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 mitral valve replacement device.
Participants will be followed for 5 years to evaluate safety and feasibility of Capstan Medical TMVR System for mitral valve replacement in humans with predominantly regurgitant mitral valves who are symptomatic and who are not good surgical candidates. Receives: Device: Capstan System transcatheter mitral valve replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of procedural success
Number of participants with successful valve deployment and freedom from death or re-hospitalization for heart failure at 30 days.
Measured: Procedure through 30 days
Secondary outcomes (2)
Technical Success
Technical success is defined as successful Capstan Valve deployment with none/trace or mild mitral regurgitation at 30 days post- procedure.
Measured: 30-Days
Freedom from MAE
Successful Capstan Valve Deployment with freedom from device- or procedure-related Major Adverse Events (MAE).
MAE is a composite of the following device or procedure related outcomes:
- All-cause mortality
- Emergency cardiac or vascular surgery, or re-intervention
- Myocardial Infarction
- Stroke
- Life-threatening bleeding
Measured: 30-days, 90-days, 6-months, 1-year, then annually to 5-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start24 Feb 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 10 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
- NCT06600191
- Sponsor's protocol ID
- CL_03945
- Status last verified
- Jul 2026
- First submitted
- 13 Sep 2024
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
- Capstan Medical TMVR Study: First-in-Human Evaluation of the Capstan TMVR System
- ClinicalTrials.gov ID
- NCT06600191
- Acronym / sponsor ID
- CL_03945
- Conditions
- Mitral Regurgitation
- Keywords
- TMVR, mitral regurgitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Capstan MedicalIndustry (pharma, biotech, devices)
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 19 Sep 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 a prospective, multi-center, non-randomized first in human study to evaluate the safety and feasibility of the Capstan Medical TMVR System for intervention in adults with moderate-severe or greater mitral 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: Capstan System transcatheter mitral valve replacementParticipants who pass all screening criteria will undergo a percutaneous procedure for the implantation of a permanent mitral valve replacement device. Participants will be followed for 5 years to evaluate safety and feasibility of Capstan Medical TMVR System for mitral valve replacement in humans with predominantly regurgitant mitral valves who are symptomatic and who are not good surgical candidates. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years at the time of consent.
- Moderate-severe (3+) or severe (4+) mitral regurgitation
- NYHA II or greater symptoms despite optimal medical treatment.
- The local multi-disciplinary heart team agrees that TMVR is the preferred treatment over surgical intervention or other available treatment options (such as TEER).
- Ability and willingness to provide written informed consent prior to any study related procedure(s).
Key exclusion criteria (23 listed)
- LVEF less than 20%
- Anatomic features (e.g., annular dimensions, neo-LVOT area, transfemoral and transseptal access, excessive MAC) unsuitable for the Capstan System
- Severe aortic valve stenosis or regurgitation
- Severe mitral stenosis
- Severe right ventricular dysfunction or severe tricuspid valve disease
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 System transcatheter mitral valve replacementThis is a first human use trial exploring a novel transcatheter mitral valve replacement implant and electro-mechanical delivery system. The device offers a minimally invasive repair for patients who have at symptomatic regurgitation who are otherwise ineligable for surgical intervention, or who have no other prospects for treatment and in whom medical therapy has already been optimised. | Device | Implant |
Primary outcome
Incidence of procedural success
Time frame: Procedure through 30 days
Number of participants with successful valve deployment and freedom from death or re-hospitalization for heart failure at 30 days.
2 secondary outcomes
Technical Success
Time frame: 30-Days
Freedom from MAE
Time frame: 30-days, 90-days, 6-months, 1-year, then annually to 5-years
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: Undecided
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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.
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capstan System transcatheter mitral valve replacement in people with Mitral Regurgitation, run by Capstan Medical at 4 sites in 4 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 23 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 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 4 sites in Australia, Brazil, Chile, 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?
Contact Anamiriam Arroyo (4087108955, anamiriam.arroyo@capstanmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of procedural success (time frame: Procedure through 30 days). 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.