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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
Ancora Heart, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Mitral Regurgitation focused on measuring Heart failure, mitral regurgitation, mitral valve

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

First Posted
July 3, 2013
Last Updated
June 7, 2017
Sponsor
Ancora Heart, Inc.
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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

Learn more about this trial

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

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