Mitral Regurgitation
Conditions
Keywords
TMVR, mitral regurgitation
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.
Interventions
DEVICECapstan 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.
Sponsors
Capstan Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of procedural success | Procedure through 30 days | Number of participants with successful valve deployment and freedom from death or re-hospitalization for heart failure at 30 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success | 30-Days | Technical success is defined as successful Capstan Valve deployment with none/trace or mild mitral regurgitation at 30 days post- procedure. |
| Freedom from MAE | 30-days, 90-days, 6-months, 1-year, then annually to 5-years | 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 |
Countries
Australia, Brazil, Chile, New Zealand
Contacts
CONTACTAnamiriam Arroyo
CONTACTChrissy Hawley, MPH
Outcome results
None listed