Clinical trial NCT01899573: Percutaneous Left Ventricular Reshaping to Reduce Functional Mitral Regurgitation and Improve LV Function
Official title: A Study of Percutaneous Left Ventricular Reshaping of Mitral Apparatus to Reduce Functional Mitral Regurgitation and Improve LV Function Using the Accucinch® System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Mitral Regurgitation
Keywords: Heart failure
mitral regurgitation
mitral valve
Lead sponsor: Ancora Heart, Inc.
Sponsor class: INDUSTRY
First posted: 2013-07-15
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Major adverse cardiac and cardiovascular events
timeFrame: 30 day
Secondary outcomes:
Other outcomes:
Locations:
city: Medellin
country: Colombia
facility: Clinica CardioVID
Study officials:
References: