|
|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P050006 S060/ PAS002 |
| Date Original Protocol Accepted |
12/07/2018
|
| Date Current Protocol Accepted |
07/06/2022
|
| Study Name |
GORE CARDIOFORM New Enrollment PAS
|
| Device Name |
GORE CARDIOFORM Septal Occluder
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Objective Performance Criterion
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Single-arm, prospective, new enrollment, multi-center study. The objective is to assess and confirm the safety
and effectiveness of the Gore Septal Occluder (GSO) device. This device was evaluated in the REDUCE
pivotal IDE study. This study is to evaluate the quality of perator education and training, and transferability of
trail experience to a post-market setting.
|
| Study Population |
18-70 years of age with a Patent Foramen Ovale (PFO) who have experienced an embolic stroke of undetermined source in the past year.
|
| Sample Size |
At least 636 patients with a limit of 10% (~63) patients will be allowed to be 61-70 years of age at the time of
enrollment. Currently 40 eligible sites in the US.
|
| Key Study Endpoints |
Primary Effectiveness Endpoint:
The proportion of subjects with ischemic stroke at 2 years in subjects with the study device implanted.
This will be compared to a performance goal (PG) of 3.8%.
Primary Safety Endpoint:
The cumulative incidence of device- or procedure-related serious adverse events through 30 days. This will be compared to a PG of 6.4%.
Secondary Effectiveness Endpoint:
Effective PFO Closure – Proportion of subjects with complete PFO closure or a trivial or small residual shunt, at 1 year.
The secondary endpoints for this study include:
• Clinically Significant New Atrial Arrhythmia
• Clinically Significant New Atrial Arrhythmia by Age
• Technical Success
• Residual Shunt Characterization
• Procedural Success
|
| Follow-up Visits and Length of Follow-up |
Follow ups at 1, 6, 12 and 24 months. Over the phone follow up out to 60 months.
|
| Interim or Final Data Summary |
| Interim Results |
Safety Results
There have been 4 site-reported serious adverse events (SAE) related to the device and 9 site-reported SAE related to the procedure. Device and procedure-related SAE included atrial fibrillation, other abnormal heart rhythms (sinus tachycardia, supraventricular tachycardia, ventricular tachycardia), pericardial effusion, cardiac tamponade, encephalopathy, presyncope, and incision site hematoma.
Effectiveness Results
99.4% (310/312) attempted implants were successful; of these, 93.6% (292/310) had an estimated shunt grade post-implant of Grade 0. There are not yet results available regarding the effectiveness endpoint of the study (ischemic stroke at 2 years).
|
| Actual Number of Patients Enrolled |
312
|
| Actual Number of Sites Enrolled |
35
|
| Patient Follow-up Rate |
Subject follow-up is ongoing. The reported follow-up rate is currently 92.6% at the 1-month study visit, 81.5% at the 6-month study visit, 77.1% at the 12-month study visit, 66% at the 24-month visit, and 34.1% at the 36-month visit
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