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

June 23, 2009 updated by: Myocor

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital
        • Contact:
        • Principal Investigator:
          • Peter Block, MD
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Recruiting
        • Evanston Northwestern Healthcare - Evanston Hospital
        • Contact:
        • Principal Investigator:
          • Theodore Feldman, MD
    • Kansas
      • Shawnee Mission, Kansas, United States, 66204
        • Recruiting
        • Shawnee Mission Hospital
        • Contact:
        • Principal Investigator:
          • Paul Kramer, MD
    • Minnesota
      • Minneapolis, Minnesota, United States, 55440
        • Recruiting
        • Abbott Northwestern Hospital
        • Contact:
        • Principal Investigator:
          • Wesley Pedersen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Intra-procedure and peri-procedure

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Myocor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Anticipated)

December 1, 2009

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

August 6, 2007

First Submitted That Met QC Criteria

August 6, 2007

First Posted (Estimate)

August 7, 2007

Study Record Updates

Last Update Posted (Estimate)

June 24, 2009

Last Update Submitted That Met QC Criteria

June 23, 2009

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 030301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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