Evaluating the use of the VentrAssist left ventricular assist device (LVAD) in a population with end-stage heart failure with data comparable to published data from similar devices

Ventracor Limited0 sites50 target enrollmentAugust 29, 2008

Overview

No summary available.

Registry

who.int

Start Date

August 29, 2008

End Date

June 30, 2009

Last Updated

6 years ago

Study Type

Observational

Sex

All

Sponsor

Ventracor Limited

•Body surface area equal to or greater than 1\.2 meters squared; need for mechanical circulatory support; ability to provide informed consent; ability to perform ongoing functions of device management; age greater than or equal to 18 years of age (French sites only)

•Stroke in the 90 days prior to enrolment or cerebrovascular disease with significant carotid stenosis; chronic renal failure; significant hepatic disease; significant pulmonary disease; clinical signs of systemic infection; fixed right ventricular failure; coagulation systemic disorders; mechanical prosthetic aortic valve; echocardiographic evidence of moderate/sever aortic/tricuspid valve insufficiency; cachexia or clinical signs of severe malnourishment; technically challenging cardiac disease e.g. hypertrophic or restrictive cardiomyopathy; previous heart transplant, cardiomyoplasty or passive restraint device insertion; contraindication to the administration of anticoagulant or antiaggregation agents; psychiatric/psychological disorders likely to impair with protocol compliance or device management; pregnancy