NCT00847964

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2009

Typical duration for phase_2

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 19, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

November 30, 2012

Status Verified

November 1, 2012

Enrollment Period

2.7 years

First QC Date

February 17, 2009

Last Update Submit

November 29, 2012

Conditions

Dilated Cardiomyopathy

Keywords

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Freedom from serious adverse events

    6 months

Study Arms (1)

Algisyl-LVR implants

EXPERIMENTAL

Algisyl-LVR implants to the left ventricular wall

Device: Algisyl-LVR

Interventions

Algisyl-LVRDEVICE

method of left ventricular restoration in patients with dilated cardiomyopathy

Algisyl-LVR implants

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Deutsche Herzzentrum München

München, Bavaria, 80636, Germany

Location

Heart Center of the Technical University of Dresden

Dresden, Germany

Location

John Paul II Hospital

Krakow, 31-202, Poland

Location

MeSH Terms

Conditions

Cardiomyopathy, DilatedHeart Failure

Condition Hierarchy (Ancestors)

CardiomegalyHeart DiseasesCardiovascular DiseasesCardiomyopathiesLaminopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Klaus Matschke, MD

    Heart Center Dresden University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2009

First Posted

February 19, 2009

Study Start

February 1, 2009

Primary Completion

November 1, 2011

Study Completion

November 1, 2012

Last Updated

November 30, 2012

Record last verified: 2012-11

Locations

DE(2)PL(1)