Capstan Medical TMVR Study: FIH

NCT ID: NCT06600191

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-24
• Study Completion Date: 2030-12-31

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 or greater mitral regurgitation who are not surgical candidates.

Conditions

Mitral Regurgitation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Implant

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.

Group Type: EXPERIMENTAL

Capstan System transcatheter mitral valve replacement

Intervention Type: DEVICE

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.

Interventions

Capstan System transcatheter mitral valve replacement

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Capstan Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Monash Health, Victorian Heart Hospital

Melbourne, , Australia

Site Status: NOT_YET_RECRUITING

Pontificia Universidad Católica de Chile

Santiago, , Chile

Site Status: RECRUITING

Auckland City Hospital

Auckland, , New Zealand

Site Status: RECRUITING

Countries

Australia; Chile; New Zealand

Central Contacts

David Ligon, MSE

Role: CONTACT

david.ligon@occam-labs.com

831-295-5461

Facility Contacts

Robert Gooley

Role: primary

research@MonashHealth.org

+61 (03) 7511 1111

Gonzalo Javier Martinez Rodriguez

Role: primary

gfloresp@uc.cl

+56 2 23543633

Mark Webster, MD

Role: primary

charissa@adhb.govt.nz

+64 21 241 2758

Other Identifiers

CL_03945

Identifier Type: -

Identifier Source: org_study_id