VIVID - Valvular and Ventricular Improvement Via iCoapsys Delivery - Feasibility Study - Full Text View

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:

MedlinePlus related topics: Coronary Artery Disease Heart Diseases Heart Failure

U.S. FDA Resources

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:

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

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 May 16, 2013