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

NCT00512005 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2009-06-24

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

Percutaneous mitral valve repair

Ventricular reshaping to treat functional mitral insufficiency

Sponsors & Collaborators

  • Myocor

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2009-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00512005 on ClinicalTrials.gov