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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Myocor.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Myocor
ClinicalTrials.gov Identifier:
NCT00512005
First received: August 6, 2007
Last updated: June 23, 2009
Last verified: May 2008
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Valvular and Ventricular Improvement Via iCoapsys Delivery (VIVID) Feasibility Study

Resource links provided by NLM:


Further study details as provided by Myocor:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Minnesota Living with Heart Failure Questionnaire, 6-Minute Hallwalk, LV Chamber Volumes [ Time Frame: 1, 3, 6, 12, 18, 24 months and annually thereafter ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Percutaneous mitral valve repair
    Ventricular reshaping to treat functional mitral insufficiency
    Other Name: iCoapsys System
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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00512005

Contacts
Contact: Cyril J. Schweich, MD 763 494 5400 schweich@myocor.com
Contact: Adam K Hoyhtya, MS 763 494 5430 hoyhtya@myocor.com

Locations
United States, Georgia
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Pamela Hyde, RN    404-712-7665    Pamela.hyde@emoryhealthcare.org   
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    cfocks@enh.org   
Principal Investigator: Theodore Feldman, MD         
United States, Kansas
Shawnee Mission Hospital Recruiting
Shawnee Mission, Kansas, United States, 66204
Contact: Millie Salkind    913-671-6516    msalkind@kcheart.com   
Principal Investigator: Paul Kramer, MD         
United States, Minnesota
Abbott Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55440
Contact: Sara Olson, RN    612-863-7601    sara.olson@allina.com   
Principal Investigator: Wesley Pedersen, MD         
Sponsors and Collaborators
Myocor
  More Information

No publications provided

Responsible Party: Cyril J. Schweich, MD / VP of Clinical and Regulatory Affairs, Myocor, Inc.
ClinicalTrials.gov Identifier: NCT00512005     History of Changes
Other Study ID Numbers: 030301
Study First Received: August 6, 2007
Last Updated: June 23, 2009
Health Authority: United States: Food and Drug Administration

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:
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Heart Failure
Ischemia
Mitral Valve Insufficiency
Ventricular Dysfunction, Left
Ventricular Dysfunction
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes
Heart Valve Diseases

ClinicalTrials.gov processed this record on July 23, 2014