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Appendix
Reference
Guides
Alarms and
Emergencies
Patient
Management
Surgical
Implant and
Explant
Monitor
Peripherals
and
Accessories
HVAD
®
PumpOverviewIntroduction
21Introduction
1.8 US Clinical Study: Destination Therapy (continued)
2. Follow-up Schedule
All patients were scheduled to return for follow-up examinations at 3, 6, 12, 18, and 24
months with a window of ± 7days, and at 30, 36, 42, 48, 54, and 60 months with a window of
± 14 days postoperatively.
Preoperative baseline assessments included demographics, medical history, physical
scale, neurocognitive exam, quality of life, and functional status. Postoperative assessments
included LVAD parameters, hemodynamics, concurrent medications, laboratory tests,
3. Clinical Endpoints
The primary endpoint was a composite of two-year survival free of disabling stroke (i.e.,
implanted device, electively transplanted or explanted due to left ventricular recovery.
Success in meeting the primary endpoint was tested for non-inferiority of the experimental
group against the control device. The non-inferiority margin of 15% was based on the
performed for each treatment using Kaplan-Meier non-inferiority log-rank methodology,
comparing study device to control using a one-sided alpha of 0.05; that is, non-inferiority will
than the non-inferiority margin. Analysis of the primary endpoint was conducted on the Per
Protocol (PP) population.
Patients were considered a success if at 730 days post implantation, the subject was alive,
originally implanted device, unless the device was removed due to heart recovery, or the
subject was electively transplanted. Patients were considered a failure if at 730 days post
post-stroke, or were urgently transplanted or had surgery for LVAD removal or replacement
due to failure of the original device.
There were seven (7) secondary endpoints, of which the following three (3) were to be
and BSA (<1.5 m
2
2
).
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