Table 6.
Ongoing randomized control trials evaluating strategies for prevention of stroke or silent embolism following AF ablation
| Trial Acronym | No. of patients, follow-up | Inclusion criteria | Primary endpoint | Treatment arms |
|---|---|---|---|---|
| Schrickel, ODIn-AF (NCT02067182)207 | 564, 1 year | Paroxysmal or persistent AF CHA2DS2-VASc score ≥ 2 Sinus rhythm and no clinical AF recurrence after 3 months blanking and 3 months observation after ablation (72 h Holter) | New silent cerebral embolism or stroke on MR at 12 months vs. baseline MR | Dabigatran vs. discontinued OAC |
| Verma, OCEAN trial (NCT02168829)208 | 1572, 3 years | AF, ≥1 stroke risk factor without recurrent AF ≥ 1 year post-ablation on serial 24 h Holter. | Composite stroke, systemic embolism, or silent stroke on brain MR. | Rivaroxaban vs. ASA |
| Wazni, Am Heart J 2022, OPTION (NCT03795298)209 | 1600, 3 years | AF, AF ablation, CHA2DS2-VASc ≥2 men or ≥3 women | Composite stroke, systemic embolism or all-cause death, non-procedural major bleeding or clinically relevant non-major bleeding | WATCHMAN FLX vs. OAC |
AF, atrial fibrillation; MR, magnetic resonance imaging; OAC, oral anticoagulation; OCEAN, Optimal Anti-Coagulation for Enhanced-Risk Patients Post-Catheter Ablation for Atrial Fibrillation; ODIn-AF, Prevention of Silent Cerebral Thromboembolism by Oral Anticoagulation With Dabigatran After PVI for Atrial Fibrillation; OPTION, Comparison of Anticoagulation With Left Atrial Appendage Closure After AF Ablation; CHA2DS2-VASc, Congestive heart failure, Hypertension, Age ≥75 years, Diabetes mellitus, Stroke, Vascular disease, Age 65_74 years, Sex category (female); ASA, acetylsalicylic acid.