JACC: Cardiovascular Interventions
Structural
Results of the U.S. Food and Drug Administration Continued Access Clinical Trial of the GORE HELEX Septal Occluder for Secundum Atrial Septal Defect
Alexander J. Javois, Jonathan J. Rome, Thomas K. Jones, Evan M. Zahn, Craig E. Fleishman, Ricardo H. Pignatelli, Larry A. Latson and Gore HELEX Continued Access Study Group
Table 9
Table 9
Clinical Success Endpoint Through 12-Month Follow-up
| 12 Months | 36 Months | 60 Months | |
|---|---|---|---|
| Evaluable patients with successful delivery | 137 | 137 | 137 |
| Clinical success endpoint | |||
| Patients evaluated | 120 | 69 | 83 |
| Clinical success | 116 (96.7) | 65 (94.2) | 79 (95.2) |
| Clinical failure | 4 (3.3) | 4 (5.8) | 4 (4.8) |
| Major device/procedure adverse event | 3 (2.5) | 4 (5.8) | 4 (4.8) |
| Adverse event | |||
| Significant leak on final core laboratory evaluation | 1 (0.8) | 0 (0.0) | 0 (0.0) |
| Patients not evaluated | 17 | 68 | 54 |
| Lost to follow-up before evaluation | 9 | 32 | 40 |
| Final defect evaluation missing | 8 | 36 | 14 |
Values shown are number or number (%).
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