First use of Capstan Medical's device for mitral valve replacement
Capstan Medical TMVR Study: First-in-Human Evaluation of the Capstan TMVR System
This study is testing a new device for replacing the mitral valve in adults with serious heart valve problems who can't have traditional surgery to see how safe and effective it is.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Capstan Medical Industry-sponsored |
| Locations | 3 sites (Melbourne and 2 other locations) |
| Trial ID | NCT06600191 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and feasibility of the Capstan Medical TMVR System in adults with moderate to severe mitral regurgitation who are not candidates for surgical intervention. It is a prospective, multi-center, non-randomized study that aims to gather data on the device's performance in a real-world clinical setting. Participants will be monitored for outcomes related to the intervention, including any adverse events. The study is designed to provide insights into the effectiveness of this novel approach to treating mitral valve issues.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with moderate to severe mitral regurgitation and symptoms despite optimal medical treatment.
Not a fit: Patients with severe aortic valve issues, significant anatomical challenges, or prior interventions that complicate valve placement may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide a less invasive treatment option for patients with significant mitral regurgitation who currently have limited options.
How similar studies have performed: While this approach is novel, similar studies in transcatheter mitral valve replacement have shown promising results in other populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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). Exclusion Criteria: * 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 * 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
Where this trial is running
Melbourne and 2 other locations
- Monash Health, Victorian Heart Hospital — Melbourne, Australia (Not_yet_recruiting)
- Pontificia Universidad Católica de Chile — Santiago, Chile (Recruiting)
- Auckland City Hospital — Auckland, New Zealand (Recruiting)
Study contacts
- Study coordinator: David Ligon, MSE
- Email: david.ligon@occam-labs.com
- Phone: 831-295-5461
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.