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.
This study is prospective cohort study. The study population consists of two different cohorts: 1)
Continued Access Study of the GORE HELEX Septal Occluder and 2) Post-Approval Study of the GORE HELEX Septal Occluder (CA-PAS Subjects HLX 06-04).
Study Population Description
The GORE HELEX Septal Occluder is a permanently implanted prosthesis indicated for the percutaneous, transcatheter
closure of ostium secundum atrial septal defects. This study will enroll approximately 200 subjects, including subjects from the Icontinued Access Study, who have been successfully implanted.
200 patients, 19 sites
Composite Clinical Success is evaluated at 12 months and is defined as a subject with
the targeted defect assessed by TTE as being either completely occluded or the residual shunt is clinically insignificant, with an absence of repeat procedure to the target ASD, and absence of any major complication.
Followup Visits and Length of Followup
The safety endpoints defined above will be evaluated annually through 5 years post procedure. The
efficacy endpoints defined above will be evaluated at year 1, 3, and 5 post-procedure.During Year 2 and Year 4 of long-term follow-up, the site will contact the subject (or legal guardian if subject is a minor) by telephone to evaluate their status. During Year 3 and Year 5 of long-term follow-up, the site will schedule subject for a follow-up visit. Follow-up visit will include physical examination, ECG, and echocardiogram. A fluoroscopy exam without contrast will be conducted at Year 5.
Final Study Results
Actual Number of Patients Enrolled
Continued Access Study: 50
Actual Number of Sites Enrolled
Continued Access Study: 13
Post-approval Study (PAS): 21 sites
Patient Followup Rate
Continued Access Study: 70% PAS: 76%
Final Safety Findings
Continued Access Study:
Major adverse events were reported in 6.0% (3/50) of subjects. These included 2
device embolizations in the first 24 hours post-procedure and 1 wire frame fracture. All of these major adverse events were device-related and occurred within 12 months.
Major adverse events (MAEs) were reported in 4.7% (10/215) of subjects through the 60-month follow- up. Out of 8 device-related MAEs, there were 2 device embolizations within the first 30 days post- procedure and 5 device removals (4 due to fracture and 1 due to device malposition).
Final Effectiveness Findings
Continued Access Study:
Clinically successful defect closure was observed in 91.5% (43/47), 84.2% (16/19), and 87.5%
(21/24) of subjects evaluated at 12, 36, and 60 months post-procedure, respectively.
Clinically successful defect closure was observed in 95.0% (171/180), 92.5% (123/133), and 94.1% (143/152) of subjects evaluated at 12, 36, and 60 months post-procedure, respectively.
Study Strengths and Weaknesses
Continued Access Study: The 50 subjects in this study provided safety and efficacy data in
support of the PMA approval for the Gore Helex septal occluder. Subjects in this study had to be re-consented for longer-term follow-up. Many of the subjects missed the 36-month follow-up and consequently, this information was not available for analysis. This also impacted the overall study follow-up. Analysis presented showed no evidence of selection bias introduced in the study due to loss-to-follow-up. This study shows the initial results of the long-term performance of this device.
The results of this study provide long-term safety and effectiveness data for the Gore Helex septal occluder. Although patient follow-up was 76%, only 4% shy of the protocol defined expectations, a sensitivity analysis showed no evidence of selection bias. Further, the data demonstrated that over 90% of the patients implanted with the investigational device maintained composite clinical success through
Recommendations for Labeling Changes
It is recommended including the PASs results on the longer-term performance of this device