Table 2.
Salient features of proposed trials on left atrial appendage closure (LAAC) in patients with ESKD and on dialysis
| Study | WatchAFIB | STOP HARM | WATCH-HD |
|---|---|---|---|
| Type | Open, randomized, controlled, multi center | Open, randomized, controlled, single center | Observational, prospective |
| Focus population | CKD 4–5 (eGFR <30 ml/min per 1.73 m2) | ESKD on dialysis >90 days or eGFR <30 ml/min per 1.73 m2 for >90 days | ESKD on hemodialysis |
| Intervention | LAAC versus VKA | LAAC versus OAC | LAAC |
| Primary outcome | Frequency of episodes of moderate or major bleeding | Time from randomization to the first occurrence of major bleeding | Composite of all-cause mortality, stroke, and bleeding |
| Follow-up | 24 months | 5 years | 24 months |
| Anticipated enrollment | 300 | 23 | 150 |
| Actual enrollment | 14 | 0 | Unavailable |
| Anticipated completion date | June 2017 | December 2021 | March 2021 |
| Status | Terminated | Terminated | Recruiting |
A search on ClinicalTrials.gov with the keywords “left atrial appendage closure/occlusion” and “chronic renal disease” yielded the above results. WatchAFIB, LAAO versus usual care in patients with atrial fibrillation and severe CKD; STOP HARM, Strategy TO Prevent Hemorrhage associated with Anticoagulation in Renal disease Management trial; WATCH-HD, Left Atrial Appendage Occlusion With WATCHMAN Device in Patients With Non-valvular Atrial Fibrillation and End-stage Chronic Kidney Disease on Hemodialysis; VKA, vitamin K antagonist; OAC, oral anticoagulants.