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

A Study of Percutaneous Left Ventricular Reshaping of Mitral Apparatus to Reduce Functional Mitral Regurgitation and Improve LV Function Using the Accucinch® System

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

Study Overview

• Status: Completed
• Conditions: Functional Mitral Regurgitation
• Intervention / Treatment: Device: AccuCinch® Ventriculoplasty System

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Medellin, Colombia
    • Clinica CardioVID

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment	Device: AccuCinch® Ventriculoplasty System; Percutaneous intervention for the treatment of functional mitral regurgitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Major adverse cardiac and cardiovascular events	30 day

Collaborators and Investigators

• Sponsor: Ancora Heart, Inc.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (ACTUAL): January 1, 2016
• Study Completion (ACTUAL): March 1, 2016

Study Registration Dates

• First Submitted: July 3, 2013
• First Submitted That Met QC Criteria: July 11, 2013
• First Posted (ESTIMATE): July 15, 2013

Study Record Updates

• Last Update Posted (ACTUAL): June 8, 2017
• Last Update Submitted That Met QC Criteria: June 7, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Heart failure; mitral regurgitation; mitral valve
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: 3566