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

Primary Purpose

Mitral Valve Regurgitation, Left Ventricular Dysfunction, Heart Failure

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Percutaneous mitral valve repair

About this trial

This is an interventional treatment trial for Mitral Valve Regurgitation focused on measuring Functional Mitral Regurgitation (FMR), Ischemic Mitral Regurgitation, Less invasive repair, Percutaneous MV repair, Mitral Valve Repair, Heart Failure, Left Ventricular Dysfunction

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Emory University HospitalRecruiting
Evanston Northwestern Healthcare - Evanston HospitalRecruiting
Shawnee Mission HospitalRecruiting
Abbott Northwestern HospitalRecruiting

Outcomes

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

Secondary Outcome Measures

Minnesota Living with Heart Failure Questionnaire, 6-Minute Hallwalk, LV Chamber Volumes

Full Information

NCT ID

NCT00512005

First Posted

August 6, 2007

Last Updated

June 23, 2009

Sponsor

Myocor

1. Study Identification

Unique Protocol Identification Number

NCT00512005

Brief Title

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

Acronym

VIVID

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2008

Overall Recruitment Status

Unknown status

Study Start Date

January 2008 (undefined)

Primary Completion Date

December 2009 (Anticipated)

Study Completion Date

December 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Myocor

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mitral Valve Regurgitation, Left Ventricular Dysfunction, Heart Failure, Mitral Insufficiency, Mitral Incompetence, Ischemic Heart Disease

Keywords

Functional Mitral Regurgitation (FMR), Ischemic Mitral Regurgitation, Less invasive repair, Percutaneous MV repair, Mitral Valve Repair, Heart Failure, Left Ventricular Dysfunction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

Percutaneous mitral valve repair

Other Intervention Name(s)

iCoapsys System

Intervention Description

Ventricular reshaping to treat functional mitral insufficiency

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Minnesota Living with Heart Failure Questionnaire, 6-Minute Hallwalk, LV Chamber Volumes

Time Frame

1, 3, 6, 12, 18, 24 months and annually thereafter

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Cyril J. Schweich, MD

Phone

763 494 5400

schweich@myocor.com

First Name & Middle Initial & Last Name or Official Title & Degree

Adam K Hoyhtya, MS

Phone

763 494 5430

hoyhtya@myocor.com

Facility Information:

Facility Name

Emory University Hospital

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pamela Hyde, RN

Phone

404-712-7665

Pamela.hyde@emoryhealthcare.org

First Name & Middle Initial & Last Name & Degree

Peter Block, MD

Facility Name

Evanston Northwestern Healthcare - Evanston Hospital

City

Evanston

State/Province

Illinois

ZIP/Postal Code

60201

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Claudia Focks

Phone

847-570-2366

cfocks@enh.org

First Name & Middle Initial & Last Name & Degree

Theodore Feldman, MD

Facility Name

Shawnee Mission Hospital

City

Shawnee Mission

State/Province

Kansas

ZIP/Postal Code

66204

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Millie Salkind

Phone

913-671-6516

msalkind@kcheart.com

First Name & Middle Initial & Last Name & Degree

Paul Kramer, MD

Facility Name

Abbott Northwestern Hospital

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55440

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sara Olson, RN

Phone

612-863-7601

sara.olson@allina.com

First Name & Middle Initial & Last Name & Degree

Wesley Pedersen, MD

12. IPD Sharing Statement

Learn more about this trial

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

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