Capstan Medical TMVR Study: FIH

ConditionMitral Regurgitation

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorCapstan Medical

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

Capstan System transcatheter mitral valve replacement
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.

Treatment groups

10 Participants

are divided into 1 treatment group

Group A: ImplantExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Incidence of procedural success

Number of participants with successful valve deployment and freedom from death or re-hospitalization for heart failure at 30 days.

Time frame

Procedure through 30 days

Secondary outcomes

Technical Success

Technical success is defined as successful Capstan Valve deployment with none/trace or mild mitral regurgitation at 30 days post- procedure.

Time frame

30-Days

Freedom from MAE

Successful Capstan Valve Deployment with freedom from device- or procedure-related Major Adverse Events (MAE). MAE is a composite of the following device or procedure related outcomes: * All-cause mortality * Emergency cardiac or vascular surgery, or re-intervention * Myocardial Infarction * Stroke * Life-threatening bleeding

Time frame

30-days, 90-days, 6-months, 1-year, then annually to 5-years