Actively Recruiting
Capstan Medical TMVR Study: First-in-Human Evaluation of the Capstan TMVR System
Led by Capstan Medical · Updated on 2025-04-04
10
Participants Needed
3
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and feasibility of the Capstan Medical TMVR System in adults with moderate-severe or greater mitral regurgitation who are not candidates for surgery. This first-in-human, prospective, multi-center study focuses on patients who remain symptomatic despite optimal medical treatment and for whom transcatheter mitral valve replacement (TMVR) is preferred over surgical or other treatment options. Participants who meet the screening criteria will undergo a minimally invasive procedure to implant the Capstan System transcatheter mitral valve replacement device. This permanent mitral valve replacement uses an electro-mechanical delivery system to provide an alternative treatment for patients unsuitable for surgery. After the procedure, participants will be followed closely for 5 years to monitor the safety and performance of the device. During the study, participants will be assessed for procedural success within 30 days, along with technical success and freedom from major adverse events at multiple time points up to 5 years. Evaluations include clinical examinations and follow-up visits to collect data on the device's safety and feasibility. Participants must be willing to complete all required follow-up visits and provide informed consent prior to enrollment.
CONDITIONS
Brief Title
Capstan Medical TMVR Study: FIH
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of consent
- Moderate-severe (3+) or severe (4+) mitral regurgitation
- New York Heart Association (NYHA) class II or greater symptoms despite optimal medical treatment
- Agreement by local multi-disciplinary heart team that TMVR is preferred over surgery or other treatments
- Ability and willingness to provide written informed consent prior to study procedures
You will not qualify if you...
- Left ventricular ejection fraction (LVEF) less than 20%
- Anatomic features unsuitable for the Capstan System, including annular dimensions, neo-LVOT area, transfemoral and transseptal access, or excessive mitral annular calcification (MAC)
- Severe aortic valve stenosis or regurgitation
- Severe mitral stenosis
- Severe right ventricular dysfunction or severe tricuspid valve disease
- Presence of intracardiac thrombus, vegetation, or mass
- Prior mitral valve intervention interfering with Capstan Valve placement
- 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 or ongoing infection requiring antibiotic therapy
- Stroke or transient ischemic attack (TIA) within 30 days of procedure
- Active peptic ulcer or gastrointestinal bleeding
- Severe pulmonary arterial hypertension with fixed pulmonary artery systolic pressure greater than 85 mmHg
- End-stage renal failure on dialysis
- Life expectancy less than 1 year
- On waiting list for heart transplant or prior heart transplant
- Pregnant or positive pregnancy test for participants of childbearing age
- Known allergy to antiplatelet therapy, heparin, or device materials
- Inability to tolerate anticoagulation or antiplatelet therapies
- Absence of appropriate venous access
- Unable to undergo transesophageal echocardiography
- Unwillingness to complete required follow-up visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants who pass all screening criteria will undergo a percutaneous procedure to implant a permanent mitral valve replacement device using the Capstan System.
1 procedure visit (in-person)
Duration - 5 years
Participants will be followed for 5 years to evaluate safety and feasibility of the Capstan Medical TMVR System, including monitoring for complications and device performance.
Visits at 30 days, 90 days, 6 months, 1 year, then annually up to 5 years
Trial Site Locations
Total: 3 locations
1
Monash Health, Victorian Heart Hospital
Melbourne, Australia
Not Yet Recruiting
2
Pontificia Universidad Católica de Chile
Santiago, Chile
Actively Recruiting
3
Auckland City Hospital
Auckland, New Zealand, 1023
Actively Recruiting
Research Team
D
David Ligon, MSE
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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