Percutaneous Left Ventricular Reshaping to Reduce Functional Mitral Regurgitation and Improve LV Function (LVRESTORESA)

Ancora Heart

Status: Completed

Conditions: Functional Mitral Regurgitation

Treatments: Device: AccuCinch® Ventriculoplasty System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01899573

3566

Details and patient eligibility

About

The study is designed to demonstrate the safety, feasibility and potential efficacy of using the AccuCinch® System to reduce functional mitral regurgitation.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Treatment

Experimental group

Treatment:

Device: AccuCinch® Ventriculoplasty System