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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P060040 / PAS001 |
| Date Original Protocol Accepted |
04/21/2008
|
| Date Current Protocol Accepted |
04/21/2008
|
| Study Name |
INTERMACS Registry
|
| Device Name |
THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
External Registry
|
| Comparison Group |
Concurrent Control
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| Analysis Type |
Analytical
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The proposed study is a prospective non-randomized observational study, with subjects obtained from the INTERMACS Registry, which included at least 84 sites with IRB approval as of December 31, 2007. The sponsor proposes to use the first 169 patients implanted with HeartMate II and the first 169 controls. If less than 169 control patients have entered the study by the time that 169 HeartMate patients have entered the study, consecutive controls will be chosen retrospectively.
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| Study Population |
All patients who are identified pre-implant in the INTERMACS database as "Bridge to Transplant (patient currently listed for transplant)" or "Possible Bridge to Transplant - Likely to be eligible" will be enrolled in the post market study. Patients implanted with the Heartmate II will comprise the study group and patients implanted with any other LVAD will comprise a concurrent comparator group. In addition, all other patients implanted with a HeartMate II during the post market study, who are not part of an IDE, and not "Bridge to Transplant (patient currently listed for transplant)" nor "Possible Bridge to Transplant - Likely to be eligible" will be analyzed as a separate group to help assess how the device is used in the community.
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| Sample Size |
169 HeartMate patients and 169 controls from the INTERMACS Registry
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| Key Study Endpoints |
Endpoints include: 1) procedural success, 2) incidence of adverse events. Bleeding adverse events will include information on date and site of bleeding, anticoagulation use, and amount of blood transfusion, 3) Device malfunctions and failures, 4) Quality of Life as measured by EuroQOL (at 3 and 6 months), 4) Neurocognitive function (Trailmaking B), assessed in a subset of sites, detailed in a separate protocol, and 5) One year post explant survival.
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| Follow-up Visits and Length of Follow-up |
All subjects and controls will be assessed at one week, one month, 3 months, 6 months, and one year post explant. Patients will be followed until one year post explant.
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| Interim or Final Data Summary |
| Interim Results |
Most adverse events occur with similar frequencies in the HeartMate II and the control groups. Hypertension is more frequent in the control group.
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| Actual Number of Patients Enrolled |
338
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| Actual Number of Sites Enrolled |
77
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| Patient Follow-up Rate |
99
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| Final Safety Findings |
The most common adverse events overall were bleeding, infection, cardiac arrhythmia, and respiratory failure. Compared to the Comparison group, HMII patients had significantly lower risk for adverse events including device malfunctions. The most common type of device malfunction was ¿external control system failure, 21 cases reported.
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| Final Effect Findings |
Success was defined as LVAS support for at least 180 days or to transplant, or to explant due to myocardial recovery and survival for at least 60 days post explant. Ninety-percent (90%) of the HMII patients achieved success compared to 79% of the Comparison patients (Fishers exact P=0.0064).
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| Study Strengths & Weaknesses |
Strengths: Follow-up rate was very high (99%); all subjects were prospectively followed; a concurrent control group was available for comparison; all data was collected and evaluated through a registry that utilized standardized methods for data collection and evaluation.
Weakness: Potential confounding variables were not controlled for in comparing subjects with controls ¿ however, baseline data was similar in the two groups.
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| Recommendations for Labeling Changes |
Labeling changes should be accomplished in accordance with the findings of the PAS.
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