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

Heart Failure Clinical Trial

— VIVID  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00512005
• Other study ID #: 030301
• Status: Recruiting
• Phase: Phase 1
• First received: August 6, 2007
• Last updated: June 23, 2009
• Start date: January 2008
• Est. completion date: December 2013

Study information

• Verified date: May 2008
• Source: Myocor
• Contact: Cyril J. Schweich, MD
• Phone: 763 494 5400
• Email: schweich[@]myocor.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2013
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Failure
• Ischemic Heart Disease
• Left Ventricular Dysfunction
• Mitral Incompetence
• Mitral Insufficiency
• Mitral Valve Insufficiency
• Mitral Valve Regurgitation
• Myocardial Ischemia
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Intervention

Device:
• Percutaneous mitral valve repair
Ventricular reshaping to treat functional mitral insufficiency

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia
United States	Evanston Northwestern Healthcare - Evanston Hospital	Evanston	Illinois
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota
United States	Shawnee Mission Hospital	Shawnee Mission	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Myocor

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra-procedural implant safety of iCoapsys System, Peri-procedural safety of the iCoapsys System, Intra-procedural MR reduction with the iCoapsys System		Intra-procedure and peri-procedure	No
Secondary	Minnesota Living with Heart Failure Questionnaire, 6-Minute Hallwalk, LV Chamber Volumes		1, 3, 6, 12, 18, 24 months and annually thereafter	No