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

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Brief Title

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

Official Title

SYM-08-001: A Pilot Study to Evaluate the Safety and Feasibility of Algisyl-LVR™ as a Method of Left Ventricular Restoration in Patients With Dilated Cardiomyopathy Undergoing Open-heart Surgery

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 in patients with dilated cardiomyopathy who are scheduled to undergo routine open
      heart surgery. Algisyl-LVR™ will be injected into the myocardium under direct visualization
      during the surgical procedure. This clinical evaluation is intended to provide the initial
      evidence of the safety and feasibility of the device as well as the procedure used to deploy
      the device. The results of the initial trial will also help to establish the utility of
      various assessments in evaluating and following the effects of the device.
    

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 are that over half of all patients presenting with HF have coronary artery
      disease (CAD) as the primary etiology. The most common etiologies among HF patients without
      CAD have been reported to be systemic hypertension and valvular disease. Irrespective of the
      etiology, the majority of patients with HF have symptoms due to an impairment of left
      ventricular (LV) myocardial function. HF is a progressive condition that results from
      myocardial damage. This damage can be caused by predisposing conditions or an acute event
      that leads to cardiac remodeling. The principal manifestation of such progression and cardiac
      remodeling is a change in the geometry and structure of the left ventricle (LV), such that
      the chamber dilates and/or hypertrophies and becomes more spherical. The cardiac remodeling
      is maladaptive and its progression leads to worsening of the clinical symptoms of HF,
      characterized by limited exercise tolerance and edema. Despite optimal medical management, HF
      is progressive in nature and patients have a mortality rate of over 50 percent in 5 years.

      Structural heart abnormalities are known to play a central role in HF, and clinical evidence
      supports a strong causal relationship between cardiac chamber dilation and heart failure.
      Because dilation, and not contractile dysfunction, appears to be responsible for the severity
      of the disease, the mitigation or prevention of the deleterious dilation process appears to
      be an important therapeutic target for HF patients. Hence, a therapy that specifically
      targets progressive LV dilatation and remodeling by reshaping and reducing the LV chamber
      size may offer an important new alternative in the treatment of HF.

      Algisyl-LVR™ is a single use, multiple component device under development for the indication
      to prevent or reverse the progression of heart failure (HF) by providing implanted
      space-occupying material in the myocardium to affect LV shape and prevent or reverse LV
      enlargement. The intended clinical benefits of Algisyl-LVR™ are to improve the failing
      heart's structure and function with an associated improvement in the patient's clinical
      status and quality of life. Data from this current study will be used to evaluate the initial
      feasibility of this novel therapeutic device.

      The objective of this pilot study is to evaluate the feasibility and safety of the
      Algisyl-LVR™ device. No formal hypothesis testing will be performed. Descriptive statistics
      will be used to summarize operator (surgeon) experience and patient outcomes. The results of
      the study will be used to assess the design of the device and feasibility of the procedures
      to use the device. The study will also guide the design and sample size of future studies.

      This study will be conducted at a several centers in Europe. The surgeon's experience with
      the use of the device will be collected and evaluated. Measures of safety and tolerability of
      Algisyl-LVR™ will be evaluated through analysis of adverse experiences, clinical laboratory
      tests, electrocardiograms, physical examinations, echocardiographic measures and magnetic
      resonance imaging (MRI). Measurements at specified time intervals will be compared to
      baseline values obtained prior to treatment.

      Patients will be evaluated prior to the procedure, during the immediate post operative
      period, and then, return to the clinic at 8 days, 3 months, 6 months, 12 months, 18 months
      and 24 months after the procedure for follow-up evaluations.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Freedom from serious adverse events


Condition

Dilated Cardiomyopathy

Intervention

Algisyl-LVR

Study Arms / Comparison Groups

 Algisyl-LVR implants
Description:  Algisyl-LVR implants to the left ventricular wall

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

11

Start Date

February 2009

Completion Date

November 2012

Primary Completion Date

November 2011

Eligibility Criteria

        Inclusion Criteria

          1. The patients must be able and willing to give written informed consent.

          2. The patients will be adult (age ≥ 18 years and  2.0 mg/dL..

         11. 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.

         12. 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.

         13. 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.
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Klaus Matschke, MD, , 

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT00847964

Organization ID

SYM-08-001


Responsible Party

Sponsor

Study Sponsor

LoneStar Heart, Inc.


Study Sponsor

Klaus Matschke, MD, Principal Investigator, Heart Center Dresden University Hospital


Verification Date

November 2012