Empiric pacemaker compared with a monitoring strategy in patients with syncope and bifascicular conduction block--rationale and design of the Syncope: Pacing or Recording in ThE Later Years (SPRITELY) study
Bibliographic record
Abstract
AIM: This study seeks to identify the optimal management strategy for patients with syncope in the context of bifascicular block and preserved left ventricular systolic function. METHODS AND RESULTS: This multicentre, randomized, open label, parallel group pragmatic randomized trial will test the hypothesis that a strategy of empiric permanent pacemaker implantation in patients with syncope and bifascicular heart block improves future outcome more effectively than a strategy of therapy guided by prolonged monitoring with an implantable loop recorder (ILR). A total of 120 patients with bifascicular block, preserved left ventricular function, and ≥ 1 syncopal spell in the preceding year will be randomized to receive a permanent pacemaker or ILR in at least 20 centres in Canada, the USA, Asia, and Europe. The primary outcome measure will be a composite of Major Adverse Study-Related Events (MASRE) in a 2-year observation period, wherein the events are death, syncope, symptomatic bradycardia, asymptomatic diagnostic bradycardia, and acute and chronic device complications. Prespecified secondary endpoints will include syncope symptoms, quality of life, and economic burden. CONCLUSION: This trial will provide high-level and generalizable evidence for the use of either permanent pacing or implantable loop recorders as a first line intervention for patients with syncope, preserved systolic function, and bifascicular block.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.007 | 0.007 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.003 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.005 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".