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Safety and Feasibility of the Injectable BL-1040 Implant

Cardiovascular Disease Clinical Trial

Official title:
Safety and Feasibility of the Injectable BL-1040 Implant

Clinical Trial Summary

This is a Phase I, multi-center, open label study designed to assess the safety and feasibility of the injectable BL-1040 implant to provide scaffolding to infarcted myocardial tissue.

Clinical Trial Description

ENDPOINTS Preliminary safety endpoints Occurrence of all adverse events including but not limited to All MIs Cardiovascular hospitalization

Serious ventricular arrhythmias sustained:

VT (symptomatic or sustained VT [duration longer than 30 seconds or 100 beats, or associated with hemodynamic collapse]) VF symptomatic bradycardia, pauses of longer than 3.0 seconds, complete atrioventricular block, Mobitz II atrioventricular block Symptomatic heart failure (NYHA criteria + physical examination OR hospitalization due to heart failure) Renal failure Stroke Death

Secondary safety endpoints Change from baseline in LV dimensions (end-systolic volume index, end-diastolic volume index) Change from baseline in regional (infarct related) and global wall motion score Change from baseline in ejection fraction Cardiac rupture NT-proBNP ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00557531
Study type Interventional
Source BioLineRx, Ltd.
Contact
Status Unknown status
Phase Phase 1/Phase 2
Start date March 2008
Completion date January 2014
View Details
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