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

NCT01899573 | Completed

• 1 other identifier: 3566
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Functional Mitral Regurgitation

Keywords

Heart failure; mitral regurgitation; mitral valve

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiac and cardiovascular events

  30 day

Study Arms (1)

Treatment

EXPERIMENTAL

Device: AccuCinch® Ventriculoplasty System

Interventions

AccuCinch® Ventriculoplasty System DEVICE

Percutaneous intervention for the treatment of functional mitral regurgitation

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ancora Heart, Inc.: lead

Study Sites (1)

Clinica CardioVID

Medellín, Colombia

Location

MeSH Terms

Conditions

Heart Failure; Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2013
• First Posted: July 15, 2013
• Study Start: October 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: March 1, 2016
• Last Updated: June 8, 2017

Record last verified: 2017-06

Locations

CO (1)