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Status:

COMPLETED

Safety and Feasibility of Algisyl-LVR™ as a Method of Left Ventricular Restoration in Patients With DCM Undergoing Open-heart Surgery

Lead Sponsor:

LoneStar Heart, Inc.

Conditions:

Dilated Cardiomyopathy

Eligibility:

All Genders

18-75 years

Phase:

PHASE2

Brief Summary

This is a pilot study to evaluate the feasibility and safety of the Algisyl-LVR™ device. The purpose of this study is to investigate Algisyl-LVR™ employed as a method of left ventricular restoration i...

Detailed Description

Heart Failure (HF) is a progressive condition that has diverse etiologies with only 50 percent of patients presenting at diagnosis with a defined reason for developing the disease. However, estimates ...

Eligibility Criteria

Inclusion

  • Inclusion Criteria
  • The patients must be able and willing to give written informed consent.
  • The patients will be adult (age ≥ 18 years and \</= 75 years) males or females who are scheduled to undergo open-chest coronary artery bypass grafting surgery and/or valve repair/replacement.
  • The patients must be on stable, evidence-based therapy for heart failure.
  • The patients will have an ejection fraction equal to or less than 40% and a left ventricular end diastolic dimension indexed to body surface area (LVEDDi) of 30 to 40mm/m2 (LVEDD/BSA).
  • Patients must have symptomatic heart failure with a New York Heart Association (NYHA) class of III or IV
  • If female, the patients must be (a) post-menopausal, (b) surgically sterile, or (c) using adequate birth control and have a negative serum pregnancy test within 7 days prior to administration of study device.
  • Exclusion Criteria:
  • Emergent open heart surgery or cardiogenic shock.
  • Right-sided heart failure.
  • Patients scheduled to undergo pulmonic or tricuspid valve replacements.
  • Patients who have undergone a previous mid-sternotomy or thoracotomy surgical procedure
  • Patients presenting with a restrictive cardiomyopathy such as due to amyloidosis, sarcoidosis, or hemochromatosis.
  • Patient with a history of constrictive pericarditis.
  • Patients with a Q wave myocardial infarction (MI) within the last 30 days.
  • Patients with a recent history of stroke (within 60 days prior to the surgical procedure)
  • A left ventricular (LV) wall thickness of the LV free-wall, at the mid-ventricular level, of less than 6 mm.
  • Patients with a serum creatinine \> 2.0 mg/dL..
  • Clinically significant liver enzyme abnormalities, i.e., AST or ALT more than two times the upper limit of normal and/or bilirubin more than 50% above the upper limit of normal.
  • The patients will not be receiving concurrently an investigational Product in another clinical trial or have received an investigational Product in another clinical trial in the 30 days prior to enrollment.
  • A life expectancy of less than 1 year or any other condition that, in the opinion of the clinical investigator, might compromise any aspect of the trial.

Exclusion

    Key Trial Info

    Start Date :

    February 1 2009

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    November 1 2012

    Estimated Enrollment :

    11 Patients enrolled

    Trial Details

    Trial ID

    NCT00847964

    Start Date

    February 1 2009

    End Date

    November 1 2012

    Last Update

    November 30 2012

    Active Locations (3)

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    Page 1 of 1 (3 locations)

    1

    Deutsche Herzzentrum München

    München, Bavaria, Germany, 80636

    2

    Heart Center of the Technical University of Dresden

    Dresden, Germany

    3

    John Paul II Hospital

    Krakow, Poland, 31-202