Table 2 Aortic, Mitral/tricuspid, and MEMO 4D substudy endpoints
Aortic substudy (n = 1650) | Mitral/tricuspid substudy (n = 300) | MEMO 4D substudy (n = 200) | |
|---|---|---|---|
Primary endpoint | Device success at 30 days (+ 14 days) adapted from VARC-3 guidelines: Technical success Freedom from mortality Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication Intended performance of the valve (mean gradient < 20 mmHg and less than moderate aortic regurgitation) | Device success at 30 days (+ 14 days), adapted from MVARC guidelines: Procedural mortality or stroke; AND Proper placement and positioning of the device; AND Freedom from unplanned surgical or interventional procedures related to the device or access procedure; AND Continued intended safety and performance of the device | Device success at 30 days (+ 14 days), adapted from MVARC guidelines: Procedural mortality or stroke; AND Proper placement and positioning of the device; AND Freedom from unplanned surgical or interventional procedures related to the device or access procedure; AND Continued intended safety and performance of the device |
Secondary endpoints | Safety and performance assessments at 30 days, 12 months, and annually after implant Collection of procedural and hospitalization information Patient outcomes | Safety and performance assessments at 30 days, 12 months, and annually after implant Collection of procedural and hospitalization information Patient outcomes | Safety and performance assessments at 30 days, 12 months, and annually after implant Collection of procedural and hospitalization information Patient outcomes |