• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

  • Print
  • Share
  • E-mail
-

The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

Learn more...


             

OSB Lead-Impella RP Prospective Study


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Progress Adequate
Application Number H140001 / PAS001
Date Current Protocol Accepted 01/23/2015
Study Name OSB Lead-Impella RP Prospective Study
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 Design Description A prospective, multicenter single -arm study enrolling new patients.

Study Population Description 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.

Data Collection 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


OSB Lead-Impella RP Prospective Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 07/24/2015 07/23/2015 On Time
one year report 01/23/2016 01/22/2016 On Time
18 month report 07/23/2016 07/22/2016 On Time
two year report 01/22/2017 01/23/2017 On Time
three year report 01/22/2018    
Final Report 05/22/2018    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

Related Links

-
-