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|
| General |
| Study Status |
Terminated |
Application Number /
Requirement Number |
H140001 / PAS001 |
| Date Original Protocol Accepted |
01/23/2015
|
| Date Current Protocol Accepted |
01/23/2015
|
| Study Name |
Impella RP Prospective Study
|
| Device Name |
IMPELLA RP SYSTEM
|
| Clinical Trial Number(s) |
NCT01777607
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adolescent: 13-18 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
A prospective, multicenter single -arm study enrolling new patients.
|
| Study Population |
Patients with right ventricular failure in need of hemodynamic support. Patients in RVF will be supported with the Impella RP until recovery, transplantation or implantation with a long-term device.
Patients that meet all eligibility criteria
|
| Sample Size |
30 consecutive patients enrolled from up to 15 US sites.
The sample size of 30 subjects for the Impella RP follows the same rationale used in the CentriMag PAS that had a sample size of 25 patients with RVF of all causes.
The rationale for choosing a sample size of 25 patients for the CentriMag PAS was based on the following:
First, the original study cohort included 24 RVAD patients.
Thus, the CentriMag clinical trial and postmarket study populations were nearly identical in size, and the nature of the patients enrolled into the PAS were anticipated to be similar to those included in the original clinical trial.
Additional consideration in selecting a sample size of 25 relates to the timeline of the original study. The 24 patients enrolled into the original trial took approximately 4 years to enroll. Approximately 16% of the patients who receive an implantable LVAD require an RVAD. Thus, the rate of enrollment has been historically slow. The enrollment of 25 patients was expected to be performed in a similar timeframe during which the practice of medicine was expected to be relatively comparable and the results meaningful.
The sample size of 30 subjects for the Impella RP PAS is 20%
higher than the CentriMag RVAS post-market study.
|
| Key Study Endpoints |
Data collected in the PAS will be based on institutional standards of care for the patient population.
Data will be collected on Case Report Forms (CRFs). Source documents include, but are not limited to, death certificate, autopsy report, laboratory reports, operative report, echocardiograms, ultrasound report, angiograms, cardiac catheterization logs and cardiac catheterization reports, patient discharge report.
Primary:
Survival at 30 days post device explant or hospital discharge (whichever is longer), or to induction of anesthesia to a longer term therapy, including a heart transplant or an implant of a surgical RVAD.
Secondary:
Safety
Rates of the following major adverse events measured at hospital discharge or to induction of anesthesia to a longer term therapy (including a heart transplant or an implant of a surgical RVAD):
Death (any cause of death and cardiac death)
Major Bleeding
Hemolysis
Pulmonary Embolism
Survival only will be assessed at 30 days (± 10 days) and 180 days (± 30 days).
Other adverse events
Device failures and malfunctions
Secondary Probable benefit
Improvement in hemodynamic parameters
Cardiac Index
Central Venous Pressure
LVAD flows after initiation of Impella RP support.
Major adverse events (MAEs) will be reviewed, adjudicated and categorized by the Clinical Events Committee.
|
| Follow-up Visits and Length of Follow-up |
180 days post explant
30 days and 180 days
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