Table 2.
Ongoing, select clinical trials assessing the role of mechanical circulatory support devices.
| Trial | Number of patients | Study type | Intervention | Control | Primary outcome |
|---|---|---|---|---|---|
| REVERSE (NCT03431467) | 96 | Multicenter RCT | Impella-CP LV Vent + VA-ECMO | VA-ECMO | 30-day survival free from MCS, OHT, or inotropic therapy |
| DanGer Shock (NCT01633502) | 360 | Multicenter RCT | Impella CP ± Inotropes | Conventional circulatory support | All-cause mortality |
| Altshock-2 (NCT04369573) | 200 | Multicenter RCT | Early IABP (within 6 h) | SoC (vasopressors/Inotropes) | 60-day survival or successful bridge to durable LVAD or OHT |
| JENAMACS (NCT04451798) | 20 | Single center prospective study | Impella CP | – | Acute hemodynamic effects measured by PAC and echocardiographic evaluation of BiV function |
| UNLOAD-AMI (NCT04562272) | 80 | Single center RCT | Impella CP for 36–48 h + SoC after PCI | SoC | Difference in LVESV, extent of post-infarct scar |
| SMART-RESCUE II (NCT04143893) | 1,000 | Multicenter prospective observational study | tMCS + medical management | Optimal medical management | All-cause mortality at 3 months |
| RECOVER IV (NCT05506449) | 560 | Multicenter RCT | Impella CP prior to PCI in STEMI + PAC | Medical management ± IABP | 30-day all-cause mortality |
| ALLOASSIST (NCT03528291) | 240 | Prospective multicenter observational study | Transient circulatory support (VA-ECMO, Impella) | SoC | In-hospital mortality from inclusion day to 6 months |
| UNLOAD-ECMO (NCT05577195) | 198 | Multicenter RCT | Impella + VA-ECMO | VA-ECMO | Time to death from any cause within 30 days |
LVESV, left ventricle end-systolic volume; RCT, randomized clinical trial, SoC, standard of care; other as described in preceding figures and tables.