N/A
N=194
Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Bridge to Cardiac Transplantation
Heart Failure, Congestive · Ventricular Dysfunction · Cardiomyopathies
Bottom Line
View on ClinicalTrials.gov: NCT00121472 ↗Enrolled (actual)
194
Serious AEs
100.0%
Results posted
Mar 2013
Primary outcome: Primary: Survival — 112; 6; 18; 19 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Thoratec HeartMate II Left Ventricular Assist System (LVAS) (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Nov 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Survival |
112; 6; 18; 19; 3; 36 | — |
| SECONDARY Clinical Reliability (Malfunctions/Failures) |
7; 2; 2; 10; 0; 0 | — |
| SECONDARY Kansas City Cardiomyopathy Questionaire (KCCQ) |
29.5; 28.8 | — |
| SECONDARY New York Heart Association (NYHA) Classification |
4.0; 2.2; 1.8; 1.7 | — |
| SECONDARY Minnesota Living With Heart Failure Questionnaire (MLWHF) |
-32.3 | — |
| SECONDARY Six Minute Walk Test (6MWT) |
149.2; 235.4; 296.8 | — |
| SECONDARY Reoperations |
8; 104; 7; 32; 8; 1 | — |
| SECONDARY Post-transplant Survival |
96; 87 | — |
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.
Eligibility Criteria
Inclusion Criteria
The following are general criteria; more specific conditions are included in the study protocol:
- 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
Exclusion Criteria
The following are general criteria; more specific conditions are included in the study protocol:
- Evidence of, or risk factors for end-organ dysfunction that would make LVAS implantation futile
- Existence of factors that would adversely affect patient survival or function of the LVAS.
- Intolerance to anticoagulant or antiplatelet therapies.
- Existence of any ongoing mechanical circulatory support other than intra-aortic balloon counterpulsation.
- Participation in any other clinical investigation that is likely to confound study results or affect study outcome.
Data sourced from ClinicalTrials.gov (NCT00121472). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.