Percutaneous Left Ventricular Reshaping to Reduce Functional Mitral Regurgitation and Improve LV Function (LVRESTORESA)
Primary Purpose
Functional Mitral Regurgitation
Status
Completed
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
AccuCinch® Ventriculoplasty System
Sponsored by
About this trial
This is an interventional treatment trial for Functional Mitral Regurgitation focused on measuring Heart failure, mitral regurgitation, mitral valve
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
Sites / Locations
- Clinica CardioVID
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Outcomes
Primary Outcome Measures
Major adverse cardiac and cardiovascular events
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01899573
Brief Title
Percutaneous Left Ventricular Reshaping to Reduce Functional Mitral Regurgitation and Improve LV Function
Acronym
LVRESTORESA
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
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ancora Heart, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study is designed to demonstrate the safety, feasibility and potential efficacy of using the AccuCinch® System to reduce functional mitral regurgitation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Mitral Regurgitation
Keywords
Heart failure, mitral regurgitation, mitral valve
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
AccuCinch® Ventriculoplasty System
Intervention Description
Percutaneous intervention for the treatment of functional mitral regurgitation
Primary Outcome Measure Information:
Title
Major adverse cardiac and cardiovascular events
Time Frame
30 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Clinica CardioVID
City
Medellin
Country
Colombia
12. IPD Sharing Statement
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Percutaneous Left Ventricular Reshaping to Reduce Functional Mitral Regurgitation and Improve LV Function
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