Functional Mitral Regurgitation Clinical Trial
— LVRESTORESAOfficial title:
A Study of Percutaneous Left Ventricular Reshaping of Mitral Apparatus to Reduce Functional Mitral Regurgitation and Improve LV Function Using the Accucinch® System
Verified date | June 2017 |
Source | Ancora Heart, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study is designed to demonstrate the safety, feasibility and potential efficacy of using the AccuCinch® System to reduce functional mitral regurgitation.
Status | Completed |
Enrollment | 8 |
Est. completion date | March 2016 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Colombia | Clinica CardioVID | Medellin |
Lead Sponsor | Collaborator |
---|---|
Ancora Heart, Inc. |
Colombia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Major adverse cardiac and cardiovascular events | 30 day |
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