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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P170011 / PAS001 |
| Date Original Protocol Accepted |
09/20/2017
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| Date Current Protocol Accepted |
07/12/2021
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| Study Name |
Impella RP-RWE Eval and Reporting
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| Device Name |
Impella RP System
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| General Study Protocol Parameters |
| Study Design |
Active Surveillance
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| Data Source |
Sponsor Registry
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The objective is to monitor post market safety and efficacy trends of the Impella system used to treat patients >= 18 years old with right heart failure.
Observational, prospective/retrospective, multicenter, single arm, registry surveillance of newly treated subjects. Patients will be treated according to standard of care and per institution guidelines.
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| Study Population |
All patients age greater than or equal to 18 years old, who received Impella RP catheters for the treatment of RV dysfunction post LVAD implantation, post myocardial infarction and post open heart surgery, after PMA post market approval and were enrolled in the cVAD registry.
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| Sample Size |
A minimum of sixty (60) newly treated patients enrolled at participating US cVAD Registry sites (44 US sites). The sample size is similar to the total sample size of 60 subjects evaluated in the PMA.
The study subjects will be divided in the following groups:
Checklist group - A minimum enrollment of 30 subjects who would have met inclusion/exclusion criteria for the premarket clinical studies, which includes at least 10 subjects that will be similar to premarket Cohort A and at least 10 subjects similar to premarket Cohort B
Real world use group - A minimum enrollment of 30 “all-comers” subjects who would not have met inclusion/exclusion criteria for the premarket studies.
Enrollment of “all-comers” subjects must continue until the full enrollment of the checklist group is completed.
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| Key Study Endpoints |
Primary Endpoint
The primary endpoint is survival rate at 30 days, post device explant or hospital discharge (whichever is longer), or to induction of anesthesia to a longer-term therapy, which includes a heart transplant or an implant of a surgical RVAD.
The primary endpoint will be reported for all patients, for each cohort treated: a) Patients that develop RVF post LVAD implantation, and b) Patients that develop RVF post myocardial infarction or postcardiotomy; and for each subgroup: checklist group and real world use group.
Secondary endpoints
During Support through device Explant the following secondary endpoints will be assessed: Central venous pressure, Cardiac index, LVAD flow and device malfunction
At 30 days or discharge the secondary endpoints to be assessed are death, bleeding hemolysis and pulmonary embolism
Additional data to be collected at 30 days, 90 days and 1 year include patient status, major cardiac and cerebrovascular adverse events (MACCE) and cardiac related readmission
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| Follow-up Visits and Length of Follow-up |
1 year; 30 days, 90 days and 1 year post Impella RP explant.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
Total enrollment: 110
Enrollment by subgroups:
Checklist Group Total: 37
Checklist Group Cohort A: 7
Checklist Group Cohort B: 30
Real-world Use Group Total: 73
Real-world Use Group Cohort A: 16
Real-world Use Group Cohort B: 57
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| Actual Number of Sites Enrolled |
29
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| Patient Follow-up Rate |
93.6%
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| Final Safety Findings |
Death prior to 30 days post device explant or discharge: 32.4% in the Checklist Group and 80.08% in the Real-World Use Group
Bleeding: 10.8% in the Checklist Group and 11.0% in the Real-World Use Group
Hemolysis: 27.0% in the Checklist Group and 15.1% in the Real-World Use Group
Pulmonary embolism: 0.0% in both groups
Device malfunction: 8.1% in the Checklist Group and 2.7% in the Real-World Use Group
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| Final Effect Findings |
Survival rate at 30 days post-device explant or hospital discharge (whichever is longer), or to induction of anesthesia to a longer-term therapy:
Checklist Group: 69.7% (23 of 33 evaluable patients)
Checklist Group Cohort A: 85.7% (6 of 7 evaluable patients)
Checklist Group Cohort B: 65.4% (17 of 26 evaluable patients)
Real-World Use Group Total: 18.6% (13 of 70 evaluable patients)
Real-World Use Group Cohort A: 31.3% (5 of 16 evaluable patients)
Real-World Use Group Cohort B: 14.8% (8 of 54 evaluable patients)
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| Study Strengths & Weaknesses |
The study’s main strengths were its representation of the real-world experience and its size in patient cohort, which was nearly twice the size of the cohort in the premarket clinical studies. The study’s main weaknesses were the missing data associated with unconfirmed status for the primary endpoint evaluation in 4 patients in the Checklist Group and in 3 patients in the Real-World Use Group as well as the missing of the minimum enrollment target of 10 patients (7 enrolled) for Cohort A (patients who develop right heart failure within 48 hours post-implantation of an FDA approved implantable surgical left ventricular assist device) in the Checklist Group largely due to slow enrollment associated with changes in clinical practice patterns.
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| Recommendations for Labeling Changes |
Yes - labeling changes were recommended and have been completed by the manufacturer. On December 5, 2022, the FDA approved updated labeling for the Impella RP device to include the final PAS results, and an update to the indications for use statement to better reflect the characteristics of the patients who may benefit the most from treatment with the device.
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