Safety and Feasibility of Algisyl-LVR™ as a Method of Left Ventricular Restoration in Patients Wi… (NCT00847964) | Clinical Trial Compass
CompletedPhase 2
Safety and Feasibility of Algisyl-LVRâ„¢ as a Method of Left Ventricular Restoration in Patients With DCM Undergoing Open-heart Surgery
Germany, Poland11 participantsStarted 2009-02
Plain-language summary
This is a pilot study to evaluate the feasibility and safety of the Algisyl-LVRâ„¢ device. The purpose of this study is to investigate Algisyl-LVRâ„¢ employed as a method of left ventricular restoration in patients with dilated cardiomyopathy who are scheduled to undergo routine open heart surgery. Algisyl-LVRâ„¢ 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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.