N/A
N=200
Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Destination Therapy
Heart Failure, Congestive · Ventricular Dysfunction · Cardiomyopathies
Bottom Line
View on ClinicalTrials.gov: NCT00121485 ↗Enrolled (actual)
200
Serious AEs
97.4%
Results posted
Oct 2013
Primary outcome: Primary: Composite Endpoint — 46; 11 percentage of participants — p=0.00000025
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Left Ventricular Assist System (LVAS) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite Endpoint |
46; 11 | 0.00000025 sig |
| SECONDARY Minnesota Living With Heart Failure Questionnaire(MLWHF) |
75.2; 76.3; 62.8; 59.1; 37.4; 43.6 | — |
| SECONDARY Kansas City Cardiomyopathy Questionnaire (KCCQ) |
27.4; 26.5; 41.8; 38.9; 63.4; 56.7 | — |
| SECONDARY New York Heart Association (NYHA) Classification |
0; 0; 100; 100; 45; 45 | — |
| SECONDARY Six Minute Walk Test (6MWT) |
182.5; 172.2; 244.2; 236.0; 316.5; 291.0 | — |
| SECONDARY Functional Status (Patient Activity Score) |
95; 94; 5; 6; 86; 90 | — |
| SECONDARY Reoperations |
9; 32; 0; 1.7; 44.4; 23.7 | — |
| SECONDARY Neurocognitive Assessments, Clock Drawing |
9.0; 8.5; 9; 9 | — |
| SECONDARY Neurocognitive Assessments, Wechsler Memory Scale-III (WMS-LM and WMS-LM Delayed) |
19.5; 20.0; 24.0; 14.0; 16; 12.5 | — |
| SECONDARY Neurocognitive Assessments, Wechsler Memory Scale-III Visual Reproduction (WMS-VR and WMS-VR Delayed) |
71.1; 76.0; 79; 68; 32; 37 | — |
| SECONDARY Neurocognitive Assessments, Wechsler Adult Intelligence Test-III, Block Design (WAIS Block) |
29.0; 25.5; 31.0; 28.0 | — |
| SECONDARY Neurocognitive Assessments, Boston Naming Test |
14.0; 14.0; 14.0; 13 | — |
| SECONDARY Wechsler Adult Intelligence Test-III, Digit Symbol (WAIS Digit) |
45; 31; 45; 34 | — |
| SECONDARY Neurocognitive Assessments, Trail Making A |
45.5; 52.0; 44.0; 52 | — |
| SECONDARY Neurocognitive Assessments, Trail Making B |
122.0; 152.5; 117.0; 188.5 | — |
Summary
The purpose of this study is to determine the safety and effectiveness of the Thoratec HeartMate II Left Ventricular Assist System (LVAS) as Destination Therapy in end-stage heart failure patients who do not qualify for cardiac transplantation.
The Destination Therapy indication for use was approved by FDA on January 20, 2010 (ref. PMA P060040/S005).
Eligibility Criteria
Inclusion Criteria
The following are general criteria; more specific conditions are included in the study protocol:
- Subjects with advanced heart failure symptoms (NYHA Class IIIB or IV) who are:
- On optimal medical management and are failing to respond; or
- In Class III or Class IV heart failure and dependent on IABP and/or inotropes; or
- Treated with ACE inhibitors or beta-blockers and found to be intolerant.
- Ineligible for cardiac transplant
- VO2max <=14 ml/kg/min
- LVEF <=25%
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 (NCT00121485). 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.