VIVID - Valvular and Ventricular Improvement Via iCoapsys Delivery - Feasibility Study (VIVID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00512005
Recruitment Status : Unknown
Verified May 2008 by Myocor.
Recruitment status was:  Recruiting
First Posted : August 7, 2007
Last Update Posted : June 24, 2009
Information provided by:

Brief Summary:
The purpose of this prospective, non-randomized, single-arm feasibility study is to evaluate safety and feasibility of the iCoapsys System in patients with functional mitral valve insufficiency caused by annular dilation and/or papillary muscle displacement.

Condition or disease Intervention/treatment Phase
Mitral Valve Regurgitation Left Ventricular Dysfunction Heart Failure Mitral Insufficiency Mitral Incompetence Ischemic Heart Disease Device: Percutaneous mitral valve repair Phase 1

Detailed Description:

Functional MR is a frequent outcome of ischemic heart disease or dilated cardiomyopathy. Patients with functional MR generally have normal valvular structures complicated by left ventricular dysfunction. Left ventricular dysfunction will often create geometric distortions that prevent complete leaflet coaptation, rendering the valve incompetent. Changes that will induce functional MR may include (i) dyskinetic or akinetic wall segments, (ii) dilation of the valve annulus or (iii) dilation of the left ventricle leading to tethering of the chordae tendinae.

The iCoapsys Device is intended to treat patients with functional MR. The device is not indicated for patients with diseased or damaged valvular structures caused by rheumatic fever, degenerative diseases, endocarditis, infiltrative diseases or congenital disorders.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Valvular and Ventricular Improvement Via iCoapsys Delivery (VIVID) Feasibility Study
Study Start Date : January 2008
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2013

Intervention Details:
    Device: Percutaneous mitral valve repair
    Ventricular reshaping to treat functional mitral insufficiency
    Other Name: iCoapsys System

Primary Outcome Measures :
  1. Intra-procedural implant safety of iCoapsys System, Peri-procedural safety of the iCoapsys System, Intra-procedural MR reduction with the iCoapsys System [ Time Frame: Intra-procedure and peri-procedure ]

Secondary Outcome Measures :
  1. Minnesota Living with Heart Failure Questionnaire, 6-Minute Hallwalk, LV Chamber Volumes [ Time Frame: 1, 3, 6, 12, 18, 24 months and annually thereafter ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key Inclusion Criteria:

  • Grade 3 or 4 functional mitral valve regurgitation per 2D echocardiography.
  • NYHA Class II and LVEF greater than or equal to 25% or NYHA Class III and LVEF greater than or equal to 30%

Key Exclusion Criteria:

  • History of pericarditis.
  • Creatinine > 2.2 at the time of the procedure
  • INR > 1.8 at the time of the procedure
  • Prior pericardial intervention (including CABG, pericardiotomy or pericardiocentesis).
  • Any endovascular therapeutic interventional or surgical procedure performed within 30 days prior to the index procedure (e.g., stent placement).
  • Any planned therapeutic interventional or surgical procedure planned within 30 days following the index procedure
  • Open chest surgery contraindication (e.g., acute respiratory distress, endocarditis, myocarditis).
  • Structural abnormality of the mitral valve
  • Valve disease resulting in insufficiency or stenosis of the aortic, pulmonary or tricuspid valve requiring intervention.
  • Pericardial effusion >5 mm via echocardiography.
  • Posterior wall end-diastolic dimension >1.3 cm.
  • Left ventricular end diastolic diameter > 7.0 cm.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00512005

Contact: Cyril J. Schweich, MD 763 494 5400
Contact: Adam K Hoyhtya, MS 763 494 5430

United States, Georgia
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Pamela Hyde, RN    404-712-7665   
Principal Investigator: Peter Block, MD         
United States, Illinois
Evanston Northwestern Healthcare - Evanston Hospital Recruiting
Evanston, Illinois, United States, 60201
Contact: Claudia Focks    847-570-2366   
Principal Investigator: Theodore Feldman, MD         
United States, Kansas
Shawnee Mission Hospital Recruiting
Shawnee Mission, Kansas, United States, 66204
Contact: Millie Salkind    913-671-6516   
Principal Investigator: Paul Kramer, MD         
United States, Minnesota
Abbott Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55440
Contact: Sara Olson, RN    612-863-7601   
Principal Investigator: Wesley Pedersen, MD         
Sponsors and Collaborators

Responsible Party: Cyril J. Schweich, MD / VP of Clinical and Regulatory Affairs, Myocor, Inc. Identifier: NCT00512005     History of Changes
Other Study ID Numbers: 030301
First Posted: August 7, 2007    Key Record Dates
Last Update Posted: June 24, 2009
Last Verified: May 2008

Keywords provided by Myocor:
Functional Mitral Regurgitation (FMR)
Ischemic Mitral Regurgitation
Less invasive repair
Percutaneous MV repair
Mitral Valve Repair
Heart Failure
Left Ventricular Dysfunction

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Ventricular Dysfunction
Ventricular Dysfunction, Left
Mitral Valve Insufficiency
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arterial Occlusive Diseases
Heart Valve Diseases