At a glance
ClinicalIndex Comparison Record- ✓Listed for cardiac transplantation
- ✓NYHA Class IV heart failure symptoms
- ✓On inotropic support, if tolerated
- ✓Despite medical therapy, the patient must meet hemodynamic criteria for cardiogenic shock
- ✕Evidence of, or risk factors for end-organ dysfunction that would make LVAS implantation futile
- ✕Factors that would adversely affect patient survival or function of the LVAS
- ✕Intolerance to anticoagulant or antiplatelet therapies
- ✕Ongoing mechanical circulatory support other than intra-aortic balloon counterpulsation
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The HeartMate II LVAS Pivotal Study Protocol, Bridge to Cardiac Transplantation
In Brief
A clinical study evaluating Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Heart Failure, Congestive and 2 related conditions. Completed, enrolled 194 participants across 36 sites in 2 countries.
Detailed Summary
The purpose of this study is to determine the safety and effectiveness of the Thoratec HeartMate II Left Ventricular Assist System (LVAS) as a bridge to cardiac transplantation in end-stage heart failure patients who are listed for cardiac transplant but are at imminent risk of dying. The HeartMate II LVAS was approved by the US FDA on April 21, 2008, as a bridge to cardiac transplantation (reference PMA P060040). It was approved for commercial distribution in Canada on May 20, 2009 (reference Medical Device Licence #79765). Patients enrolled into the clinical trial will continue to be followed until all have reached a clinical outcome.
Study Details
Timeline
Interventions
Implantation of ventricular assist device to provide hemodynamic support