Baseline Results and Cost-effectiveness Study - VentrAssist left ventricular assist device

Not Applicable

Completed

• Conditions: End stage heart failure; Cardiovascular - Coronary heart disease

• Registration Number: ACTRN12608000438358
• Lead Sponsor: Ventracor Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-08-29
• Study Completion: 2009-06-30
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: Observational
• Study Design: Not specified