Capstan Medical TMVR Study: FIH

Capstan Medical

Status: Enrolling

Conditions: Mitral Regurgitation

Treatments: Device: Capstan System transcatheter mitral valve replacement

Study type: Interventional

Funder types: Industry

Identifiers

NCT06600191

CL_03945

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Implant

Experimental group

Description:

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.

Treatment:

Device: Capstan System transcatheter mitral valve replacement