Status:
RECRUITING
Capstan Medical TMVR Study: FIH
Lead Sponsor:
Capstan Medical
Conditions:
Mitral Regurgitation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06600191
Start Date
February 24 2025
End Date
December 1 2030
Last Update
April 4 2025
Active Locations (3)
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1
Monash Health, Victorian Heart Hospital
Melbourne, Australia
2
Pontificia Universidad Católica de Chile
Santiago, Chile
3
Auckland City Hospital
Auckland, New Zealand, 1023