Functional Mitral Regurgitation
Conditions
Keywords
Heart failure, mitral regurgitation, mitral valve
Brief summary
The study is designed to demonstrate the safety, feasibility and potential efficacy of using the AccuCinch® System to reduce functional mitral regurgitation.
Interventions
Percutaneous intervention for the treatment of functional mitral regurgitation
Sponsors
Ancora Heart, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>18 years * Subjects with clinically significant mitral regurgitation (MR 2+ and above) * Ejection Fraction ≥ 25% * Stable cardiac medical regimen for heart failure for at least 1 month * Stable NYHA Classification for at least 1 month * Subject is eligible for cardiac surgery * The subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent
Exclusion criteria
* Myocardial infarction within 90 days of the intended treatment with the device * Prior surgical, transcatheter, or percutaneous mitral valve intervention * Any intervention for coronary artery disease (CAD) within the last 30 days prior to treatment, or unrevascularized multivessel coronary disease * Hemodynamic instability or the need for emergent surgery * Non-ambulatory NYHA Class IV symptoms of heart failure or subjects requiring IV inotropic support * Subjects in whom sufficient quality of echocardiography (TTE and TEE) cannot be obtained * Echocardiography evidence of primary mitral valve disease causing MR or MS, * Evidence of mitral valve stenosis with an estimated valve area less than 3.0 cm2 * Mitral valve prosthesis or pathology that would prevent adequate function of the GDS Accucinch System * Estimated GFR of \<30ml/min/1.73m2 * Greater than mild mitral annular calcification observed by fluoroscopy * Presence of aortic valve prosthesis * Moderate to severe aortic valve stenosis or calcification observed by echocardiography or fluoroscopy * Severe aortic arch calcification or mobile aortic atheroma observed by echocardiography or fluoroscopy * Active bacterial endocarditis * History of bleeding diathesis or coagulopathy * History of stroke within the prior 6 months * Subjects in whom anticoagulation is contraindicated * Any clinical evidence that the investigator feels would place the subject at increased risk with the placement of the device. * Concurrent medical condition with a life expectancy of less than 12 months * Currently participating in an investigational study * Co-morbid conditions that place the subject at an unacceptable surgical risk (e.g. severe chronic obstructive pulmonary disease, hepatic failure, immunological abnormalities, and hematological abnormalities) * Subjects with indication for concomitant surgery such as coronary artery bypass graft (CABG), aortic valve reconstruction or replacement, tricuspid repair or replacement, left ventricular remodeling surgery and congenital repair * Any cardiac resynchronization therapy within the last 3 months prior to treatment * Subjects on high dose steroids or immunosuppressant therapy * Female subjects who are pregnant, of child bearing potential or lactating * Subjects who are unable or unwilling to comply with the follow-up schedule and requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major adverse cardiac and cardiovascular events | 30 day |
Countries
Colombia
Outcome results
None listed