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.
Transit. Adolescent B (as adults) : 18-21 yrs,
Detailed Study Protocol Parameters
Study Design Description
The purpose of this study is to characterize the removability of the Attain StarFixModel 4195
Left Ventricular Lead (StarFix). This study will evaluate the lead removal success in patients that are indicated for left ventricular lead removal.
Study Population Description
The Attain StarFix Model 4195 steroid eluting, transvenous lead with deployable lobe fixation is intended
for chronic pacing and sensing of the left ventricle via the cardiac vein, when used in conjunction with a compatible implantable pulse generator or implantable cardiac defibrillator. The study population consists of subjects of either genders that are indicated for a Model 4195 or a non-Model 4195 Medtronic lead extraction who meet all inclusion criteria are eligible for this study. The baseline date (from Baseline CRF) is designated as the date on which the inclusion criteria are verified and must be within 30 calendar days prior to left ventricular lead extraction attempt. The extraction procedure must occur at least 181 days after implant for subjects included in the primary objective.
120 study subjects (Model 4195 and non-Model 4195 implanted subjects) will be enrolled in the
study for the primary objective. A separate cohort of up to an additional 20 subjects with Model 4195 implanted from 90 to 180 days leads will be enrolled, 25 sites
The primary objective of the study is to compare the removal success of the Model
4195 lead to other Medtronic left ventricular lead models and to test the null hypothesis that the probability of removal of the Model 4195 left ventricular lead is less than other Medtronic left ventricular leads by 20%. The primary end point (extraction success rate) will be first evaluated at the end of three years or when 40 subjects are enrolled in the Model 4195 lead group, whichever comes first.
Followup Visits and Length of Followup
Subjects will be followed at one month after extraction attempt. The one month follow-up can
be completed via in person visit, telephone or data collection from primary care center. Subjects will be exited from the study upon completion of the one month follow-up or after all Adverse Events have been resolved, whichever is later.
Final Study Results
Actual Number of Patients Enrolled
Actual Number of Sites Enrolled
Patient Followup Rate
Final Safety Findings
Extraction success is either: 1) removal of all targeted leads and all lead material from
the vascular space, with the absence of any permanently disabling complication or procedure related death; or 2) removal of all targeted leads except for the retention of a small portion of the lead that does not negatively impact the outcome goals of the procedure. This may be the tip of the lead or a small part of the lead (conductor coil, insulation, or the latter two combined) when the residual part does not increase the risk of perforation, embolic events, perpetuation of infection or cause any undesired outcome
The observed extraction success rate for model 4195 LV leads implanted greater than 181 days was 92.5% (37/40) compared to a success rate of 98.8% (163/165) for Non Model 4195 Leads.
Final Effectiveness Findings
Study Strengths and Weaknesses
Strength: The high follow-up rate: 89.77% Weaknesses: Limited number of leads studied: 40 Model 4195 leads
Recommendations for Labeling Changes
Yes (Labeling updates has been approved in P060039/S056)