In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
Follow-up rate below 80%,
More than 10% of the primary endpoint data missing
General Study Protocol Parameters
Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N)
Transit. Adolescent B (as adults) : 18-21 yrs,
Detailed Study Protocol Parameters
Study Design Description
Objective: To evaluate the safety and efficacy of the HeartWare System in a commercial setting
using data from patients enrolled in the INTERMACS database. The HeartWare VAS performance in a ¿real world¿ setting will be compared to other continuous flow, intra-corporeal left ventricular assist devices in the INTERMACS database, as assessed by primary endpoint of success and secondary endpoints including INTERMACS adverse event rates.
Design: This is a multi-center, prospective, contemporaneously controlled trial of newly enrolled patients. There will be two groups - the Treatment group, patients who receive a HeartWare VAS, and a contemporaneous Control group, patients who receive a continuous flow, intra-corporeal LVAD other than the HeartWare VAS.
Study Population Description
Patients entered into the INTERMACS database who receive a HeartWare System (treatment group) and contemporaneous
patients who receive a continuous flow, intra-corporeal LVAD other than HeartWare (control).
¿ FDA approved durable mechanical circulatory support device implanted
after PMA approval of the HeartWare System
¿ Signed consent for registry
¿ Consent form not signed
600 HeartWare patients and 600 control patients of continuous flow, intra- corporeal LVADs other than
the HeartWare System. A total of 1200 patients are required to satisfy the subgroups of interest (i.e. gender and race).
For Scenarios 1-2:
At least 310 implanted females and at least 310 implanted non-whites (155
HeartWare and 155 Control), calculated using a non-inferiority with a 10%
margin, using a one-sided 5% significance level, will provide 90% power at
180 days. At least 12 non-IDE sites will be included. For Scenarios 3:
The sample size of 155 patients will provide greater than 90% power to test the study hypothesis that the lower 95% (5% significance level) one-sided confidence limit is greater than 80%.
The primary endpoint is success (alive, transplanted, or explanted for recovery) at 180 days on
the originally implanted device. Patients who are explanted for recovery must survive at least 60 days post-explant. The
denominator of the simple proportion includes all enrolled and implanted patients. This will be stratified by gender and race.
Secondary endpoints are:
¿ Overall survival on device
¿ INTERMACS adverse events
¿ Quality of Life measures (as measured by the EuroQol EQ-5D-5L and
¿ Functional Status (as measured by the 6 minute walk and / or VO2 max)
¿ Post-stroke QOL, Functional and Neurocognitive assessments
Device Malfunction and thrombus are also captured.
The INTERMACS database does not capture Modified Rankin Scale (MRS) scores, but it does capture data from which an MRS score may be derived. An independent neurologist will analyze on a blinded basis INTERMACS data for patients who have experienced a stroke event to impute MRS scores.
Followup Visits and Length of Followup
Two years post implant
Follow-up will occur at discharge, 1 week, 1 month, 3 months, 6