Status:
COMPLETED
Percutaneous Left Ventricular Reshaping to Reduce Functional Mitral Regurgitation and Improve LV Function
Lead Sponsor:
Ancora Heart, Inc.
Conditions:
Functional Mitral Regurgitation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study is designed to demonstrate the safety, feasibility and potential efficacy of using the AccuCinch® System to reduce functional mitral regurgitation.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01899573
Start Date
October 1 2013
End Date
March 1 2016
Last Update
June 8 2017
Active Locations (1)
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1
Clinica CardioVID
Medellín, Colombia