Extended Data Table 2 Reasons for premature study exit of investigational and control patients before index ablation
From: Dual-energy lattice-tip ablation system for persistent atrial fibrillation: a randomized trial
Randomization | Reason for early exit | Reason details |
|---|---|---|
Investigational | Screening failure after assignment (did not meet eligibility criteria) | Exclusion no. 31. Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in this study or compliance with follow-up requirements or would impact the scientific soundness of the clinical trial results |
Investigational | Screening failure after assignment (did not meet eligibility criteria) | Inclusion no. 5. Willing and able to comply with all baseline and follow-up evaluations for the full length of the study |
Investigational | Screening failure after assignment (did not meet eligibility criteria) | Inclusion no. 5. Willing and able to comply with all baseline and follow-up evaluations for the full length of the study |
Investigational | Screening failure after assignment (did not meet eligibility criteria) | Exclusion no. 18. Left ventricular ejection fraction < 35% |
Investigational | Screening failure after assignment (did not meet eligibility criteria) | Inclusion no. 5. Willing and able to comply with all baseline and follow-up evaluations for the full length of the study |
Investigational | Excluded (no mapping/ablation procedure with study device) | Excluded due to lack of study device/catheter |
Investigational | Subject death | Hemorrhage intracranial |
Control | Screening failure after assignment (did not meet eligibility criteria) | Inclusion no. 5. Willing and able to comply with all baseline and follow-up evaluations for the full length of the study |
Control | Excluded (no mapping/ablation procedure with study device) | Excluded due to lack of study device |
Control | Excluded (no mapping/ablation procedure with study device) | Excluded due to lack of study device |
Control | Excluded (no mapping/ablation procedure with study device) | Excluded due to lack of study device |
Control | Excluded (no mapping/ablation procedure with study device) | Excluded due to lack of study device |
