None listed
Conditions
Brief summary
The VentrAssist left ventricular assist device will provide circulatory support for patients with end-satge heart failure with results comparable to other left ventricular assist devices
Interventions
The VentrAssist left ventricular assist device is an active implantable medical device used to bridge patients (maintain circulatory support) until a donor heart may be found, or may be implanted as destination therapy (for the remainder of the participants life). Patients will be followed up at clinic visits until transplant, explant, death or 24 months post implant. Each visit will take approxiamtely 30-60 minutes to complete.
Sponsors
Ventracor Limited
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
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)
Exclusion criteria
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
Outcome results
None listed