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Confirmation Trial of the Acorn CorCap Cardiac Support Device (CSD) at the Same Time as Mitral Valve Repair

NCT00630266 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2009-06-18

No results posted yet for this study

Summary

The purpose of this study to evaluate patients when they have an Acorn CorCapTM Cardiac Support Device (CSD) placed around their heart for the treatment of heart failure at the same time as their mitral valve surgery.

The CorCapTM CSD is intended to support the heart, potentially preventing further dilation that is associated with progressive heart failure, thereby potentially preserving or improving heart function.

Conditions

Interventions

DEVICE

CorCap CSD

The surgical procedure includes implantation of the CorCap CSD with concommitant mitral valve surgery through a sternotomy.

Sponsors & Collaborators

  • Acorn Cardiovascular, Inc.

    lead INDUSTRY

Principal Investigators

  • Steven F Bolling, MD · University of Michigan

  • Michael A Acker, MD · Hospital of the University of Pennsylvania, Cardiovascular Medicine; Penn-Presbyterian Medical Center

  • Mario Pompili, MD · Kaiser Permanente Northern California Heart Transplant Program

  • James Wudel, MD · Nebraska Heart Institute

  • Randall Starling, MD · The Cleveland Clinic

  • Mark J Zucker, MD, JD · Newark Beth Israel

  • Renzo Cecere, MD · Royal Victoria Hospital, McGill University

  • Pat Pappas, MD · advocate christ medical center

  • Robert Brewer, MD · Henry Ford Hospital

  • Jeff Cope, MD · Lancaster General Hospital

  • Edward Raines, MD · BryanLGH Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

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

Countries

  • United States
  • Canada

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 NCT00630266 on ClinicalTrials.gov